Assessing adverse events and clinical outcomes in patients with multiple sclerosis on Rituximab versus biosimilar
In a real-world practice setting of Kaiser Permanente Northern California (KPNC), what are the effects of switching from Rituxan to Truxima as primary therapy for patients with multiple sclerosis (MS). Aims are to determine and compare the rates of adverse events for MS patients in KPNC on Rituxan versus Truxima during the study period and to assess and compare the rates of MS flares for MS patients in KPNC on Rituxan versus Truxima during the study period.
Investigator: Nguyen-Huynh, Mai
Funder: TPMG Physician Researcher Program
Genetic and social determinants of pharmacological health outcomes in ancestrally diverse populations
The overarching objective of this proposal is to discover genetic and social determinants of drug safety and efficacy in previously-understudied populations using electronic health record (EHR)-linked biobanks. Aims include determining the impact of social factors on drug effects, identifying genome-wide polymorphisms predictive of drug effects in historically-excluded populations, and discovering eQTL determinants of drug response.
Investigator: Iribarren, Carlos
Funder: National Human Genome Research Institute
Targeted metabolomics for early pregnancy prediction of gestational diabetes mellitus
This study will apply a targeted metabolomics approach to the prediction of gestational diabetes from a single blood sample collected in the first trimester of pregnancy and stored for the Research Program on Genes, Environment and Health pregnancy cohort study, which recruited 24,000 pregnant participants during early pregnancy through delivery within Kaiser Permanente Northern California. This large racially and ethnically diverse pregnancy cohort, with stored biospecimens, and clinical data and perinatal health outcomes from electronic health records, provides an excellent opportunity to conduct a nested case-control study among women without prior diabetes to identify a metabolite profile predicting subsequent gestational diabetes diagnosis during mid-gestation. This study will involve a specialized targeted metabolomics approach that can reveal risk of gestational diabetes significantly sooner than conventional tests.
Investigator: Gunderson, Erica
Funder: University of Toronto
Collaboration on Studies Examining Health Conditions in Pediatric and Adult Populations Focused on Asians and Asian Subgroups
The ethnic diversity of younger and older US populations is continuing to increase. This research program supported by the Stanford Center for Asian Health Research and Education will support the continuation of existing studies within our team examining cardiometabolic and cardiovascular risk, diabetes, and asthma in pediatric and adult populations focused on Asian subgroups
Investigator: Lo, Joan
Funder: Stanford University
Biomarker of Pancreatic B-cell Loss Predicting Progression to Type 2 Diabetes After Gestational Diabetes
The goal of this study is to identify unmethylated INS DNA reflecting higher type 2 diabetes risk in women after gestational diabetes pregnancy and to evaluate unmethylated INS DNA as a potential mediator of the lactation duration and intensity association with up to 50% lower relative risk of progression to type 2 diabetes in women after gestational diabetes. The study combines the two largest collections worldwide of longitudinal biospecimens from serial annual 2-h 75 g research OGTTs and in-person research visits in 1,033 women with gestational diabetes followed prospectively since early postpartum (6-9 wks) through 2 years post-delivery, and up to 12 years via electronic health records for type 2 diabetes testing in the KPNC Study of Women, Infant Feeding and Type 2 Diabetes After Gestational Diabetes (SWIFT) funded by NICHD and NIDDK (Gunderson, PI), and women enrolled from 12 weeks to 1 year postpartum and followed through 4 years post-delivery in Tianjin GDM Observational study (TGDM-O) funded by the European Foundation for the Study of Diabetes (Hu, PI
Investigator: Gunderson, Erica
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake (NUDGE-FLU)
NUDGE-FLU was a nationwide, pragmatic, registry-based, cluster-randomized implementation trial during the 2022-23 influenza season in Denmark. NUDGE FLU randomized >960,000 Danish citizens aged 65 years or older to usual care or 9 different behaviorally informed electronic letters (9:1:1:1:1:1:1:1:1:1) promoting influenza vaccination. Letters explaining the potential cardiovascular benefits of influenza vaccination demonstrated a modest but significant improvement in vaccination uptake, a finding which was particularly pronounced in patients without vaccination in the prior influenza season, potentially indicating the ability to nudge a vaccine hesitant group.
Investigator: Bhatt, Ankeet
Funder: Sanofi Pasteur S.A.
TRANSFORM3: Evaluation of Implementation Strategies of Teaching, Technology, and Teams to Optimize Medical Therapy in Cardiovascular Disease (“T3”)
This initiative evaluates strategies (including technology-based decision support, referral to a virtual guideline-directed medical therapy team, and general educational tools/resources for clinicians and patients) to improve use of guideline-directed therapeutics known to lower cardiovascular events among patients with heart failure, atrial fibrillation and type 2 diabetes/ arteriosclerotic cardiovascular disease.
Investigator: Bhatt, Ankeet
Funder: American College of Cardiology Foundation
Improving Care by Defining the Role of ElectroNic HealTh Record-Based Alerts In a Fully Integrated Health Care Delivery SYstem for Worsening Heart Failure (IDENTIFY-WHF)
IDENTIFY-WHF is a prospective, virtual, parallel-group, randomized, quality improvement intervention of EHR-based alerts for worsening heart failure (WHF) to improve the adoption of guideline-directed medical therapy (GDMT) within an integrated and learning health care delivery system. Approximately 1,000 participants will be randomized 1:1 to the intervention or usual standard of care. The primary outcome is the proportion of adults experiencing WHF with an increase in the number of prescribed GDMT classes at 30 days post-discharge from the hospital or ED.
Investigator: Ambrosy, Andrew
Funder: TPMG Delivery Science Projects Program
Genetic and Environmental Factors in Hyperlipidemia and Its Treatment
Study has 3 aims: Identify and characterize common and rare genetic variants and environmental factors underlying untreated LDL-cholesterol, HDL-cholesterol, triglycerides and total cholesterol in each of four race/ethnicity groups; identify common and rare genetic variants and environmental factors underlying response to statin and fibrate treatment of lipidemia; and characterize gene-environment interactions underlying plasma lipoprotein concentrations and their treatment.
Investigator: Iribarren, Carlos
Funder: University of California, San Francisco, Project Grant
Optimization of statin regimens for atherosclerotic cardiovascular disease prevention using polygenic risk scores and real-world evidence
This study will use the GERA cohort to develop a polygenic risk score-guided precision medicine tool for statin treatment decisions. It will develop an algorithm that predicts baseline atherosclerotic cardiovascular disease (ASCVD) and statin-induced ASCVD relative risk reduction incorporating ASCVD polygenic risk score on top of traditional ASCVD risk prediction tools.
Investigator: Iribarren, Carlos
Funder: National Heart, Lung, and Blood Institute
Hip Fracture Risk and Outcomes in Older Black Women
This study examines hip fracture risk and outcome in older Black women using data from Kaiser Permanente Northern California. The study will examine the predictors of hip fracture, fracture risk prediction, and morbidity and mortality following hip fracture.
Investigator: Lo, Joan
Funder: KP National Office of Community Health
Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE)
CREST-2 is a multicenter randomized trial of intensive medical management with or without revascularization in patients with asymptomatic high-grade carotid stenosis.This study is a long-term observational extension of participants in the CREST-2 randomized clinical trial (C2LOE) to describe the comparative treatment efficacy over a longer period of expected benefit from revascularization than can be accomplished in the parent trial alone. The study will end
follow-up and report treatment differences when the last patient has been followed for 2 years.
Investigator: Nguyen-Huynh, Mai
Funder: National Institute of Neurological Disorders and Stroke
Calculator for Length of Use of Bisphosphonates (CLUB)
Despite the wide availability of bisphosphonate drugs that reduce fracture risk, treatment rates have fallen, attributable to concerns for atypical femoral fractures and osteonecrosis of the jaw. While risk/benefit ratios of bisphosphonate treatment for osteoporosis remain highly favorable in the first 3-5 years, fracture-prevention benefit wanes with longer treatment and risks of side effects increases. This study will estimate the risks/benefits of bisphosphonate drug holidays; determine the cost effectiveness of continuing vs discontinuing a bisphosphonate after 3 years; and develop and validate a risk factor calculator to guide decisions about length of bisphosphonate use.
Investigator: Lo, Joan
Funder: National Institute on Aging
Trajectory of PRimary and SEcondAry HospitalizaTions for Worsening Heart Failure (TREAT-WHF)
The primary objective of the TREAT-WHF study is to leverage a diverse and contemporary heart failure cohort with rigorously adjudicated worsening heart failure events to describe the crude rate of all-cause and cause-specific health care utilization and the independent association of secondary heart failure hospitalizations with outcomes after adjusting for traditional risk factors. This study builds on our prior research that showed machine learning-based natural language processing algorithms can accurately identify hospitalizations for worsening heart failure and resulted in a more than twofold increase in the perceived population burden of hospitalizations for worsening heart failure compared to diagnostic coding alone.
Investigator: Ambrosy, Andrew
Funder: Lexicon Pharmaceuticals, Inc.
Coronary Artery Risk Development in Young Adults (CARDIA)
This landmark 35-year study describes the distribution of coronary heart disease risk factors in a biracial cohort of men and women aged 18 to 30 years at entry; and identifies habits, behaviors and lifestyles that are associated with initial levels of risk factors, with the evolution of risk factors, and increasingly with clinical events.
Investigator: Bhatt, Ankeet
Funder: National Heart, Lung, and Blood Institute
Effect of reproductive history on longitudinal change in cardiac, vascular, and lipid parameters
The NHLBI NGHS enrolled 871 girls (50% Black and 50% white) in 1987 at age 9 or 10 and examined them up to 17 times, to age 27. This resulted in 7 echocardiogram reports from ages 20-27, multiple saved samples, and reproductive history questionnaires. We will conduct detailed lipoprotein sizing and functionality assessments from stored and new samples, cardiovascular imaging, and repeat echocardiograms at median age 46. Our aims are to determine the specific lipoprotein particle size distribution and function changes which occur from before to short- and long-term post-pregnancy; determine whether pregnancy-related cardiac adaptations result in long-term alterations in cardiac structure and function, thereby increasing CVD risk for women in their forties; and to test whether parity increases cardiovascular risk independently of socioeconomic status in Black and white women.
Investigator: Gunderson, Erica
Funder: National Heart, Lung, and Blood Institute
Polygenic Risk Scores for Advancing CVD Risk Stratification among Asymptomatic Adults
Leveraging the GERA Cohort to evaluate the performance of a 12-SNP PRS for CVD against the Pool Cohorts Equation across ethnic groups; validate MEGASTROKE Consortium PRS_32 for ischemic stroke; and assess the interplay between genetic background and lifestyle factors. We will evaluate the independent and joint contributions of PRS_12, smoking status, Mediterranean diet pattern and meeting physical activity recommendations to risk of CVD. Separate analyses for each ethnic group.
Investigator: Iribarren, Carlos
Funder: GENinCode PLC
Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen in Acute Coronary Syndrome (CLEAR ACS) Study
The overall objective of the Cholesterol Lowering via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome ACS (CLEAR ACS) study is to determine the efficacy, safety, and tolerability of bempedoic acid/ezetimibe (BA/E) in a contemporary and real-world population, enriched for older adults, women, and underrepresented racial/ethnic groups, of adults with a recent acute coronary syndrome (ACS) event independent of use of statin therapy before the ACS event. CLEAR ACS study is a prospective, virtual, electronic health record (EHR)-based, randomized, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial embedded within Kaiser Permanente Northern California’s fully integrated and learning health care delivery system.
Investigator: Ambrosy, Andrew
Funder: Esperion Therapeutics, Inc.
Clinical Characteristics and Outcomes of Patients with Asymptomatic, Moderate Severity Aortic Stenosis (ASSESS-AS)
The prevalence of aortic stenosis (AS), currently estimated to be 4% among adults 70 years of age and over is projected to double by 2040 and triple by 2060. However, the prevalence, clinical characteristics, and outcomes of the condition have not been well-characterized in a contemporary, demographically diverse cohort with asymptomatic moderate AS. We are leveraging a natural language processing (NLP)-based approach applied to state-of-the-art electronic health record semi-structured data to describe (1) the prevalence and clinical characteristics, (2) all-cause and cause-specific healthcare utilization and all-cause death, and (3) independent clinical predictors of all-cause and cause-specific morbidity and mortality among a diverse real-world cohort of asymptomatic adults with moderate AS.
Investigator: Ambrosy, Andrew
Funder: Edwards Lifesciences LLC
Skeletal Health Outcomes among US Asian Women
The burden of osteoporosis has increased as the US population over age 65 years has increased. Ethnic diversity in the U.S. has also increased. This is the first large scale US study of fracture outcomes among Asians and ethnic subgroups that will inform ethnic-specific osteoporosis counseling and fracture prevention care. Among older women receiving care in an integrated healthcare system, we aim to compare differences in the incidence of hip, vertebral, and major osteoporotic fracture, between white and Asian women, including comparison between various Asian ethnicities; characterize the association between femoral neck BMD and hip, vertebral, humerus, and wrist fracture in Asian women and between ethnic subgroups; and examine the predictive accuracy of Fracture Risk Tools for Asian women and ethnic subgroups and to determine whether inclusion of Asian-specific fracture data improves fracture risk prediction for Asians.
Investigator: Lo, Joan
Funder: National Institute on Aging
Young Adult and Midlife Transitions in Physical Activity and Sedentary Behavior with Heart Failure Risk and Progression: Coronary Artery Risk Development in Young Adults (CARDIA)
This CARDIA ancillary study will examine the longitudinal relations of 35-year changes in reported physical activity from young adulthood to late midlife with indicators of subclinical heart failure collected at late midlife, and evaluate interaction in these relations by race, sex, and stages of adulthood. It will also examine the longitudinal relations of 15-year changes in accelerometer-based physical activity and sedentary behavior during midlife with indicators of subclinical heart failure during late midlife, and evaluate interaction in these relations by race and sex.
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
GUARD-AF: reducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals
To determine if one-time screening for atrial fibrillation using the 14-day Zio XT patch leads to a reduced risk of stroke compared with usual care among adults aged 70 years or older without prior known atrial fibrillation or atrial flutter.
Investigator: Go, Alan
Funder: Bristol-Myers Squibb Company
Cardiovascular Health Associations with Minority Stress: Behavioral Evaluations and Self-Reported Sociopsychological Outcomes by SOGI Status (CHAMBERS)
In CARDIA Year 35 exam: Assess whether sexual minority and gender minority (SGM) individuals in CARDIA have increased odds of objectively-determined traditional cardiovascular disease (CVD) risk factors and poorer CVD outcomes compared to their non-SGM counterparts. Determine whether self and/or perceived SGM stigmas associate with minority stress theory linked psychosocial or behavioral CVD risk and outcomes in cross-section and over time. Determine the role of structural SGM stigma on CVD risk factors and outcomes among SGM CARDIA participants by measuring attitudes toward SGM individuals at the community level.
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
Determinants and Cardiovascular Consequences of Disparities in Sleep and Circadian Rhythms between Black and White Adults
Determine the independent and joint contributions of behavioral, psychosocial and clinical characteristics over 35 years of CARDIA participation on sleep and circadian characteristics in middle-aged adults. Identify the relationship of sleep and circadian characteristics to the pathophysiologic stress response. Determine the contribution of sleep and circadian characteristics on the management of hypertension and diabetes.
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
Collaborative Cohort of Cohorts for COVID-19 Research
The goal of this study is to obtain COVID-19 surveillance study (questionnaire and serology) in 6 cohort studies funded by NHLBI including the CARDIA study. A surveillance questionnaire will be administered 3 times at approximately 6 month intervals and blood will be collected for COVID-19 serology during the participants’ attendance at the Year 35 CARDIA study exam. The data will be used to enhance understanding of the prevalence of COVID-19 and the precursors and sequelae of COVID-19 infection in a multi-ethnic population of participants across the 6 studies.
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
The Use of Natural Language Processing to Characterize Episodes of Outpatient Worsening Heart Failure within an Integrated Health Care Delivery System
This study will assess the accuracy of using a natural language processing-based approach to retrospectively identify episodes of outpatient worsening heart failure in unstructured electronic health record data within an integrated health care delivery system and assess the burden and clinical characteristics of these outpatients.
Investigator: Ambrosy, Andrew
Funder: Northern California Community Benefit Programs
A Multicenter, Randomized, Placebo-controlled Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events in Medically Ill Outpatients with Acute Symptomatic COVID-19 (PRE
This virtual, pragmatic randomized clinical trial will evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic COVID-19 infection.
Investigator: Go, Alan
Funder: Janssen AIzheimer Immunotherapy R＆D
Acute Emergency Care and Outcomes for Stroke, Myocardial Infarction, and Surgery During the COVID-19 Pandemic in Kaiser Permanente Northern California: Implications for Care Delivery During COVID-19 Recovery Phase and Future Surges
The decreased trend in patients seeking care for acute stroke, acute MI, and acute surgical presentations during the COVID-19 pandemic is concerning for potential long-term morbidity, mortality, rehabilitation costs, and preventable downstream health care utilization. We aim to assess the effects of the shelter-in-place order on acute stroke, AMI, and surgical care and outcomes and downstream consequences on the health care system.
Investigator: Nguyen-Huynh, Mai
Funder: Garfield Memorial Fund
Outpatient Worsening Heart Failure in an Integrated Health Care Delivery System: An Innovative Approach to Characterizing a Novel Clinical Entity
While the Affordable Care Act-mandated Hospital Readmission Reduction Program launched in 2012 has modestly reduced readmissions, an unintended consequence has been the shift of a significant fraction of heart failure (HF)-related care to the outpatient setting. However, little is known about the epidemiology, clinical profile, treatment patterns, and/or outcomes of outpatient worsening HF (WHF). To address these critical knowledge gaps, we propose (1) to systematically describe the contemporary epidemiology, clinical characteristics, treatment patterns, and outcomes associated with outpatient WHF and (2) to evaluate the impact of an episode of outpatient WHF on generic and disease-specific HRQOL in the context of a fully integrated health care delivery system.
Investigator: Ambrosy, Andrew
Funder: National Heart, Lung, and Blood Institute
Fetal and Early Postnatal Influences on Child Metabolic Health After Gestational Diabetes
This 5-year RO1 study will determine the independent contribution of fetal exposures and early postnatal lifestyle factors on subsequent development of child adiposity and metabolic health among youth (ages 9 to 13 ) exposed to gestational diabetes in utero. The research study will evaluate cardiometabolic health factors and lifestyle behaviors in youth whose mothers were diagnosed with gestational diabetes and enrolled in the prospective, longitudinal SWIFT Study from 2008 to 2011. This study will conduct an in-person research exam and will coordinate the research exams in the children with 10-year follow up exams in the SWIFT women to reclassify glucose tolerance.
Investigator: Gunderson, Erica
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
KP NOURISH: Evaluation of the Clinical Utility of Medically-Tailored Meals in Adults with Chronic Conditions
This pragmatic randomized clinical trial funded through National and NCAL Community Health/Benefits is testing the impact of medically-tailored meals and enhanced nutritional counseling compared to usual care on clinical and patient-centered outcomes in hospitalized adults with targeted medical conditions being discharged home from KP Santa Rosa or Santa Clara Medical Centers.
Investigator: Go, Alan
Funder: Kaiser Permanente Program Offices
A Multi-center, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults with Severe COVID-19
This multi-center, multi-country retrospective cohort study will assess the clinical course and outcome of adults with severe COVID-19 not treated with remdesivir using a 7-point ordinal scale for clinical outcomes on Day 14 and all-cause mortality at Day 28 after admission. This study complements ongoing clinical trials of remdesivir for the treatment of severe COVID-19 infection.
Investigator: Go, Alan
Funder: Gilead Sciences, Inc.
Transcatheter Mitral-Valve Repair in Patients with Heart Failure and Functional Mitral Regurgitation – Potential Scope and Clinical Benefit of Early Adoption at an Integrated Healthcare Delivery System
This study will look at the clinical benefit of early adoption of the MitraClip device in patients with heart failure in a real-world setting. Previous research showed patients who have the MitraClip procedure have 50% fewer hospitalizations for heart failure within the next 24 months than those who receive the standard of care. The MitraClip is used to reduce mitral regurgitation, a common side effect of heart failure, that affects quality of life and functioning, increases risk of hospitalization, and reduces survival despite medical therapy.
Investigator: Ambrosy, Andrew
Funder: Abbott Laboratories
Evaluating Inpatient and OutpatIent Encounters Within a Learning and Integrated Health Care Delivery Organization Due to Worsening Heart Failure (UTILIZE-WHF)
This study will assess the inpatient and outpatient health care utilization and mortality of patients with heart failure and how it relates to their degree of systolic dysfunction.
Investigator: Ambrosy, Andrew
Funder: Novartis International AG
Pragmatic RandomIzed Trial of Icosapent Ethyl for High-Cadiovascular Risk Adults (MITIGATE)
The MITIGATE Study will evaluate the real-world clinical effectiveness of icosapent ethyl (Vascepa®) compared to usual care in patients with established atherosclerotic cardiovascular disease. The study will evaluate whether the drug, which is used to reduce the risk of heart disease and stroke, can also prevent or reduce the risk of complications from viral respiratory illnesses in older adults with heart disease.
Investigator: Ambrosy, Andrew
Funder: Amarin Corporation
Metabolites Preceding Progression to Type 2 Diabetes in Women after Gestational Diabetes
This study will identify biochemical markers that predict type 2 diabetes mellitus in women after a pregnancy complicated by gestational diabetes mellitus (GDM). Ultimately, the results of this study may lead to improved testing and more effective, personalized interventions to prevent diabetes in women after GDM pregnancy.
Investigator: Gunderson, Erica
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Extended Window for Thrombectomy – Have we extended our resources appropriately and effectively
Study will evaluate the performance of the RAPID software interpretation of CT perfusion (CTP) studies and determination of qualifications for endovascular therapy (EST). It will include a retrospective case review of prospectively collected data on consecutive stroke patients seen during the extended window for EST and screened with CTP in 2019 and 2020. It will also determine the rate of EST among those screened for the extended window and the rate of favorable 90-day functional outcome (defined as mRS 0-2) among those treated with EST. It will include a retrospective cohort study of prospectively collected data on consecutive Kaiser Permanente patients screened during the EW by telestroke neurologists in the Stroke EXPRESS program and who underwent EST.
Investigator: Nguyen-Huynh, Mai
Lifecourse CVD Risk and Midlife Cognitive Trajectories and Brain Aging: Implications for Alzheimer’s and Dementia Prevention
Determinants
of cognitive aging may begin decades prior to the development of pathological
brain changes, but it is unknown whether risk factors such as hypertension
and diabetes exert their influence as early as young adulthood. In this
CARDIA Year 35 ancillary study, we plan to expand cognitive testing to assess
10-year cognitive change and address: 1) independent associations of 10-year
midlife cognitive decline with average level and trend in cardiovascular
disease (CVD) risk factors including BMI, blood pressure, and fasting
glucose, assessed over 35 years from young adulthood to midlife; 2)
association of 10-year midlife cognitive decline with level and trend in
subclinical CVD markers derived from carotid ultrasound, coronary CT, and
echocardiography; and 3) whether CVD risk factors and subclinical CVD markers
are associated with brain aging indices in midlife, derived from brain MRI
data obtained on 700 CARDIA participants at Year 30.
Investigator: Sidney, Stephen
Funder: National Institute on Aging
Gestational diabetes phenotypes, glucose tolerance transitions and lifestyle behaviors related to cardiovascular risk status
The Study of Women, Infant Feeding, and Type 2 Diabetes after GDM Pregnancy (SWIFT) is a prospective, community-based cohort of mothers aged 20-45 years of age and diagnosed with gestational diabetes mellitus (GDM) who delivered a singleton pregnancy longer than 35 weeks gestation at Kaiser Permanente Northern California in 2008-2011. The new study leverages the SWIFT cohort’s rich datasets, and measures blood pressure and novel biomarkers in blood samples obtained at the NIDDK funded 10-year follow up exam. The goal of this ancillary study will evaluate the relationship of GDM phenotype and subsequent transitions in glucose tolerance after GDM pregnancy to cardiovascular disease risk profiles, inflammation, and novel lipid biomarkers as well as effect modification by lifestyle behaviors.
Investigator: Gunderson, Erica
Funder: National Heart, Lung, and Blood Institute
Community-based, Longitudinal Cohort of Patients with Interstitial Lung Disease (ILD) in the Kaiser Permanente Northern California (KPNC) Health System
The KPNC-ILD cohort will consist of approximately 10,000 patients with interstitial lung disease. It will be built through electronic health recordbased case identification using an algorithm that will be further developed. We anticipate optimizing the existing KPNC-ILD algorithm and having a fully operational case identification process. The KPNC-ILD algorithm will be useful to clinical researchers worldwide who are interested in using large electronic health recordbased datasets to identify ILD cohorts.
Investigator: Iribarren, Carlos
Funder: Genentech, Inc.
Leveraging Multi-omics Approaches to Examine Metabolic Challenges of Obesity in Relation to Cardiovascular Diseases
This project will generate longitudinal plasma metabolomic profiles in the CARDIA study cohort to better understand underlying molecular mechanisms for cardiovascular disease (CVD). We will identify metabolites and metabolic pathways related to CVD risk factors and CVD incidence; identify specific metabolites that mediate pathways from genomic CVD-susceptibility to CVD risk factors and incidence; identify metabolites and major metabolic pathways to CVD risk factors and incidence that are modified by obesity; and test most-promising metabolic pathways for CVD etiology using targeted metabolic profiling.
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
Multimorbidity and Treatment-Related Outcomes in Older Heart Failure Patients
This multicenter Cardiovascular Research Network (CVRN) collaborative project will examine the risks and benefits of targeted medical therapies used for heart failure across the spectrum of multimorbidity burden and level of left ventricular systolic function, as well as several targeted comorbidity dyads including heart failure plus diabetes and heart failure plus anemia.
Investigator: Go, Alan
Funder: National Institute on Aging
Healthy Eating as a Means for Active Living in Heart Failure (HEAL-HF) Study
There is an unmet clinical need to better understand the impact of lifestyle choices with respect to diet and nutrition in high-risk heart failure patients who have been recently hospitalized. We will conduct a survey-based project using a combination of questionnaires to assess 4 clinically relevant domains: food access and security, dietary composition and quality, nutritional awareness and understanding, and attitudes toward nutrition-related research. The survey itself will take no more than 15 to 30 minutes to complete and will be administered via telephone to 1,000 consecutive patients recently hospitalized with a primary diagnosis of heart failure who are responsible for their own meal planning. In addition to the survey elements, outcomes of interest will include subsequent heart failure hospitalization, all-cause hospitalization, and mortality occurring within 30 days. These outcomes will be passively collected via Kaiser Permanente HealthConnect electronic health records.
Investigator: Go, Alan; Ambrosy, Andrew; Gordon, Nancy
Funder: Northern California Community Benefit Programs
Community-Based, Longitudinal cohort of Patients with Interstitial Lung Disease in the Kaiser Permanente Northern California Health System
The study aim is to optimize the Kaiser Permanente Northern California (KPNC) Interstitial Lung Disease (ILD) algorithm and establish the KPNC-ILD cohort. The KPNC-ILD cohort will consist of approximately 10,000 patients with ILD. It will be built through electronic health record-based case identification using an algorithm. We will optimize the existing algorithm and have a fully operational case identification process to build the cohort. The algorithm will be useful to clinical researchers worldwide who are interested in using large, electronic health record-based datasets to identify ILD cohorts.
Investigator: Iribarren, Carlos
Funder: Genentech, Inc.
Disparities in Residual Risk in Patients Receiving Statins for Primary or Secondary Prevention at an Integrated Health Care Delivery System
Patients with risk factors for or established atherosclerotic cardiovascular disease (ASCVD) remain at high risk for first-time or recurrent nonfatal and fatal events, despite guideline-directed medical therapy for primary and secondary prevention. In fact, even among patients who are appropriately treated with lipid-lowering therapies and have an LDL-C that is at goal and in line with current guideline recommendations, substantial residual risk persists. There is now a considerable body of evidence to suggest that plasma triglycerides contribute to residual risk and play a causal role in atherogenesis and ASCVD risk. Furthermore, older adults, women, and nonwhite participants may have a disproportionately different prevalence of elevated triglyceride levels and be at incrementally greater risk of recurrent ASCVD events. Given the public health implications, it is important to better understand the extent of age-, gender-, and ethnicity/race-related disparities in residual risk.
Investigator: Ambrosy, Andrew
Funder: Amarin Corporation
MINERVA Biomarkers Substudy
We will conduct assays of a selected panel of cardiac, metabolic, and cancer biomarkers in 3,000 blood samples collected by the MINERVA (MultIethNic Study of BrEast ARterial Calcium Gradation and CardioVAscular Disease) Study and stored at the Kaiser Biobank. The biomarker data will be merged with the study datasets to perform association analyses with risk factors and outcomes. The proposed biomarker panel incudes Cystatin C, apolipoprotein A1, apolipoprotein B, Lp(a), BNP, Gamma prime fibrinogen, SuPAR, Galectin-3, hs-troponin, and a cancer biomarker panel.
Investigator: Iribarren, Carlos
Funder: Abbott Laboratories
Optimizing Atrial Fibrillation Management in Chronic Kidney Disease
As an extension of the ATRIA-CVRN collaboration in Kaiser Permanente Northern California and Southern California, we will examine the recent use and associated outcomes of different management strategies for atrial fibrillation in adults with and without underlying chronic kidney disease.
Investigator: Go, Alan
Funder: National Heart, Lung, and Blood Institute
Sleep Disordered Breathing and Outcomes in Chronic Kidney Disease
The overall objective of this ancillary study to the ongoing NIH-sponsored Chronic Renal Insufficiency Cohort (CRIC) study is to evaluate sleep-disordered breathing (assessed by home sleep-monitoring using the WatchPAT200 device) as a potential predictor of clinical and patient-centered outcomes in a diverse cohort of 2,200 adult participants with mild-to-moderate chronic kidney disease.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Prenatal Blood Pressure Patterns to Predict Pregnancy-Related Hypertension and Later-Life Cardiovascular Risk
This study utilizes clinical prenatal-care blood pressure measurements and other clinical and biochemical variables to develop models for the early prediction of hypertensive disorders of pregnancy, and evaluates the relationship of pregnancy blood-pressure patterns to new onset hypertension and cardiovascular diseases in women within more than a decade later.
Investigator: Gunderson, Erica
Funder: National Heart, Lung, and Blood Institute
Nor-Cal-CSC for Northern California Regional Coordinating Center
The Northern California Regional Coordinating Stroke Center (NorCal-CSC) is a joint effort between U.C. San Francisco and selected medical center(s) within Kaiser Permanente as part of the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Trials Network. This project has two aims. First, NorCal-CSC will become a resource to any network principal investigator to plan, initiate, and complete a clinical trial in the neurosciences. Second, NorCal-CSC will provide training opportunities to medical students, residents, fellows, and faculty within the network to plan and conduct clinical trials.
Investigator: Nguyen-Huynh, Mai
Funder: National Institute of Neurological Disorders and Stroke
Chronic Renal Insufficiency Cohort Study IV (CRIC-4)
This is a renewal of the Chronic Renal Insufficiency Cohort (CRIC) Study Clinical Center at Kaiser Permanente Northern California and UCSF, which will continue long-term follow-up of existing participants with chronic kidney. The overall goals are to examine the links between different measures of renal dysfunction of a broad set of clinical and patient-centered outcomes, as well as prediction of adverse outcomes in the setting of chronic kidney disease.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Acute Kidney Injury among Patients with Chronic Kidney Disease
This ancillary project to the multicenter Chronic Renal Insufficiency Cohort (CRIC) Study will examine the incidence and associated predictors of episodes of acute kidney injury among a prospective cohort of adults with underlying chronic kidney disease, and the associated clinical complications.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Population-Based Pharmacogenomic Assessment of QT Prolongation
Cardiotoxicity of commonly prescribed medications, typically assessed by electrocardiographic features such as prolongation of the QT interval, has regulatory effects and is associated with potentially fatal outcomes. This project aims to advance understanding of the genetic basis for drug cardiotoxicity and its downstream consequences by leveraging the extensive data resources of the Kaiser Permanente Northern California Research Program on Genes, Environment and Health (RPGEH), and the ability to link these data to other health plan databases, namely Kaiser Permanente Northern California’s pharmacy, electrocardiogram, and outpatient/inpatient utilization databases. Longitudinal analyses of the QT interval over up to 20 years will be conducted in the large and ethnically diverse Genetic Epidemiology Research in Adult Health and Aging (GERA) cohort of the RPGEH. Genetic loci that influence adverse drug reactions will be identified and characterized, and the associated biological pathways and tissues will be investigated. This study will also examine: a) genetic predictors of adverse outcomes (e.g., ventricular arrhythmias and Torsade de Pointes), b) whether the identified gene-by-drug interactions are associated with these adverse outcomes, and c) degree of mediation by QTc prolongation.
Investigator: Iribarren, Carlos
Funder: National Heart, Lung, and Blood Institute
TRANSFORM-HF (ToRsemide compArisoN with furoSemide FOR Management of Heart Failure) Study
Patients with heart failure will be randomized 1:1 to either oral torsemide or oral furosemide prior to hospital discharge. The primary endpoint will be all-cause mortality over the follow-up period. Secondary endpoints are hospitalizations, quality of life, and depression.
Investigator: Ambrosy, Andrew
Funder: National Heart, Lung, and Blood Institute
Improving Stroke Prevention for High-risk Atrial Fibrillation by Discharge Redesign Using Electronic Clinical Decision Support
This is a retrospective cohort study to describe the effect of adding direct oral anticoagulants to the Kaiser Permanente formulary on overall rates of oral anticoagulant initiation at the time of discharge for emergency department and inpatients with high-risk non-valvular atrial fibrillation or flutter across 21 medical centers from 2010-2017. The results of this study will inform the design of an electronic clinical decision support tool to aid emergency physicians and hospitalists in the comprehensive management of patients with atrial fibrillation or flutter. The tool will include evidence-based guidance on rate reduction, cardioversion, and stroke prevention. The tool will be evaluated in a pilot study at three large Kaiser Permanente medical centers in Northern California. If the tool improves outcomes of patient care, expansion of tool access across the region for further study will be considered.
Investigator: Vinson, David
Funder: The Permanente Medical Group
Long-Term Outcome in Unruptured Brain Arteriovenous Malformation Patients
This study has three aims: 1) To identify predictors of hemorrhage and poor outcome in the untreated course of unruptured brain arteriovenous malformation patients, 2) To identify predictors of hemorrhage and poor outcome in the treated course of unruptured brain arteriovenous malformation patients, and 3) To compare five-year outcomes in untreated versus surgically-treated unruptured brain arteriovenous malformation patients.
Investigator: Zaroff, Jonathan
Funder: National Institute of Neurological Disorders and Stroke
Optimizing Management and Outcomes for Patients with Valvular Heart Disease
This project aims to characterize the management and outcomes of valvular heart disease for patients within Kaiser Permanente Northern California. It will include evaluation of surveillance patterns for moderate and severe valve disease, assessment of clinical outcomes in those with guideline-recommended surveillance, development of methods to ensure evidence-based follow-up and subsequent therapy for patients, and calculation of contemporary estimates for the natural history of disease for the most prevalent valvular heart conditions.
Investigator: Solomon, Matthew
Funder: The Permanente Medical Group
How Fast is Fast Enough? Assessing Door-to-Needle Times and Outcomes of Stroke Patients Receiving Acute Thrombolysis Therapy Under the Kaiser Permanente Northern California Stroke EXPRESS Program
With stroke treatment, there is a general belief that “time is brain.” However, there has been no published data examining specifically the association between door-to-needle times for acute treatment with intravenous alteplase in stroke patients and 90-day outcomes. In 2016, the Kaiser Permanente Northern California Stroke EXPRESS program rolled out at all 21 primary stroke centers with significant improvement in door-to-needle times. This study has two major aims: 1) to determine if there is an association between door-to-needle times and mortality at discharge and at 90-day post-treatment in patients who receive acute thrombolysis treatment with intravenous alteplase at Kaiser Permanente Northern California, and 2) to determine if there is an association between door-to-needle times and 90-day favorable functional outcome (defined as mRS 0-2) in patients who receive acute thrombolysis treatment with intravenous alteplase at Kaiser Permanente Northern California.
Investigator: Nguyen-Huynh, Mai
Funder: The Permanente Medical Group
Network and Infrastructure Support for Development of Interdisciplinary Aging Research
For adults aged 40 to 75 years, randomized trials provide conclusive evidence that statins reduce the risk of initial and secondary cardiovascular disease (CVD) events. However, there is limited evidence that statins reduce CVD events in individuals over the age of 75 who do not have clinically recognized CVD, and older adults may be at greater risk of adverse effects from statins. It is important for statin treatment of this age group to be rigorously evaluated in a randomized clinical trial. The primary objective of this pilot study is to understand recent patterns of statin use and the feasibility of conducting a possible trial on the net effects of statins in adults more than 75 years old without clinical CVD.
Investigator: Go, Alan
Funder: National Institute on Aging
Predicting Readmission After Stroke Study (PRESS)
Hospital readmissions are a tremendous burden on patients, their families, and the health care system. In 2008, the Centers for Medicare and Medicaid Services began publicly reporting hospital-level, risk-standardized, 30-day readmission and mortality rates for acute myocardial infarction and heart failure. Stroke survivors also have high risk of new illness, worsened known diseases, functional decline, and a high death rate. Readmission rates of 20 to 27 percent within one year have been reported. A systematic review of predictors of hospital readmission after stroke yielded no risk-standardized models for comparing hospital readmission performance or predicting readmission risk after stroke. This project aims to create a risk-adjusted predictive model for re-hospitalization after ischemic stroke using retrospectively and prospectively collected patient-level and hospital-level data, and to validate the model retrospectively and prospectively.
Investigator: Nguyen-Huynh, Mai
Funder: National Institute of Neurological Disorders and Stroke
Hispanic Chronic Renal Insufficiency Cohort (HCRIC) Study
This is a renewal of an ongoing ancillary study to the Chronic Renal Insufficiency Cohort (CRIC) Study to examine whether rates of loss of kidney function and subclinical and clinical cardiovascular disease varies among Hispanics versus other race/ethnic groups, after accounting for traditional risk factors. Among Hispanics with chronic kidney disease, this study will also examine the contribution of the metabolic syndrome, lifestyle factors, and patient-centered characteristics to the risk of adverse renal and cardiovascular-related outcomes.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Multiple Chronic Conditions and Adverse Outcomes in Older Adults with Heart Failure
This ancillary pilot study to the Cardiovascular Research Network Heart Failure Consortium will evaluate the frequency and association of multiple chronic condition burden with clinical outcomes in adults who have diagnosed heart failure.
Investigator: Go, Alan
Funder: National Institute on Aging
Anticoagulation Length of ThErapy and Risk of New Adverse evenTs In Venous thromboEmbolism (ALTERNATIVE) Study
This observational study involves a collaboration between KPNC, KPSC and UCSF that will examine clinical and patient-centered outcomes (recurrent VTE, hemorrhage, treatment satisfaction, and quality of life) associated with different lengths of anticoagulation therapy after an initial 3-month treatment course in patients with venous thromboembolism and explore whether there are differences by type of oral anticoagulant.
Investigator: Go, Alan
Funder: Patient-Centered Outcomes Research Institute
Multiethnic Study of Breast Arterial Calcium Gradation and CVD
Specific study aims are: 1) To establish a multi-ethnic cohort between the ages of 60 and 79 years with equal representation of white, African-American, Asian and Hispanic/Latina women. All participants will be recruited at the time of their regular screening mammography and will be free of clinical CVD at baseline. A new, validated densitometry method will be used to estimate BAC mass (in milligrams) using digital mammograms; 2) To document race/ethnic variation in BAC mass and to examine associations of BAC mass with sociodemographic background, family history of CVD, traditional and novel CVD risk factors, reproductive health factors, psychosocial factors, selected mineral metabolism factors, selected medication use (statins and nitrogen-containing bisphosphonates), breast size and sleep-related factors; and 3) To elucidate the role of BAC mass in the prediction of coronary heart disease (CHD), cerebrovascular disease, heart failure, peripheral vascular disease and total CVD and to determine whether adding BAC mass to prediction models based on traditional risk factors improves classification of risk for total CVD and its components. Accomplishing these aims will provide novel insights into the utility of BAC mass as a screening tool to assess CVD risk.
Investigator: Iribarren, Carlos
Funder: National Heart, Lung, and Blood Institute
A Randomized, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin in Patients with Acute Ischemic Stroke
The primary objective of the trial is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction, and death) in patients with acute ischemic stroke or transient ischemic attack.
Investigator: Nguyen-Huynh, Mai
Funder: AstraZeneca PLC
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multi-center, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1-to-1 ratio to endarterectomy versus no endarterectomy, and another will randomize patients in a 1-to-1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed. The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage.
Investigator: Nguyen-Huynh, Mai; Avins, Andrew; Chang, Robert
Funder: National Institute of Neurological Disorders and Stroke
Identifying Modifiable Biomarkers/Mediators for Disease Progression and Cardiovascular Risk in Chronic Kidney Disease
This ancillary study to the multi-center Chronic Renal Insufficiency Cohort (CRIC) aims to leverage newer proteomic techniquest to identify novel pathways associated with cardiovascular complications in the setting of impaired kidney function.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Tubular Secretion in Chronic Kidney Disease
This ancillary study to the ongoing prospective Chronic Renal Insufficiency Cohort (CRIC) aims to examine the predictive value of different markers of tubular secretion compared with estimated and measured glomerular filtration for progression of chronic kidney disease, cardiovascular events and death.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Partnership for Anemia: Clinical and Translational Trials in the Elderly (PACTTE)
Within the CVRN-HF Network, and in collaboration with NIA-sponsored PACTTE consortium investigators, we will examine the following among a large, multi-center cohort of elderly patients with heart failure with reduced or preserved left ventricular systolic function: 1) to characterize the contemporary frequency of testing for and prevalence of anemia; 2) to assess the frequency, timing and extent of evaluation for reversible causes of anemia in those with documented anemia; 3) to evaluate contemporary adverse event rates by hemoglobin level; and 4) to examine the feasibility of conducting a potential pragmatic clinical trial of systematic evaluation of anemia in elderly heart failure patients.
Investigator: Go, Alan
Funder: National Institute on Aging
Pregnancy-Related Risk Factors and Glucose Intolerance in Women during Midlife
This is an ancillary study to the CARDIA Study, a multi-center longitudinal study of 5,115 black and white women and men (18-30) enrolled in 1985-1986, and followed at in-person exams serially through 2011. The study will evaluate pregnancy-related changes in cardiometabolic risk factors and their lasting effects on progression to glucose intolerance in women from the reproductive years through midlife.
Investigator: Gunderson, Erica
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Heart Failure and Atrial Arrhythmias in CKD
This ancillary project to the CRIC Study will examine the incremental value of selected biomarkers on top of patient and clinical characteristics to identify the subset of adults with chronic kidney disease at high risk for developing incident clinical heart failure or surrogate measures of impaired cardiac function.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
10-Year Changes in Objectively-Measured Physical Activity and Sedentary Behavior in the CARDIA Cohort
The goal of this study is to evaluate changes in both self-reported and objectively-measured PA and SB from young adulthood (ages 18-30 years) to late midlife (ages 48-60 years) in relation to disease risk (obesity, hypertension, dyslipidemia, type 2 diabetes, subclinical atherosclerosis and clinical endpoints), and markers of successful aging (physical and cognitive function, and cellular aging, specifically, telomere length and DNA copy number).
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
Genomics of Blood Pressure-induced Target Organ Damage
The study’s aims are to: 1) ascertain the genomic contribution of common genetic variants to blood pressure (BP) variation within and between multiple ethnic groups; 2) conduct Mendelian randomization experiments using all new and known BP-associated variants to investigate the interplay of genetic BP risk with hypertensive target organ damage including left ventricular hypertrophy, renal dysfunction, and clinical cardiovascular disease across ethnic groups; and 3) perform deep whole-genome sequencing in very extreme individuals for systolic blood pressure to uncover the entire spectrum of allele frequencies.
Investigator: Iribarren, Carlos
Funder: National Heart, Lung, and Blood Institute
Pharmacogenomics of Statin Therapy
This study will recruit statin users with: 1) a major acute coronary event (n=150), 2) new onset type 2 diabetes (n=150), 3) statin-induced myopathy (n=150), and controls free of all 3 conditions (n=300). We will then conduct genetic, transcriptomic, proteomic and/or metabolic profiling studies to identify biomarkers of statin response and side effects. We will use prescription fills and ICD-9 codes to identify statin users who are current Kaiser members that meet one of the three conditions described above. For each condition, a frequency-matched control group will be formed. Recruited individuals will complete a self-reported survey and provide a blood sample from which an aliquot will be used to generate a lymphoblastoid cell line. A separate aliquot will be used to store frozen viable cells for the future creation of ips cells, and plasma and DNA will be stored.
Investigator: Iribarren, Carlos
Funder: National Institute of General Medical Sciences
Defining a Comprehensive Reference Profile of Circulating Human Extracellular RNA: A CARDIA Ancillary Study
Blood and other body fluids harbor abundant and stable extracellular RNAs (exRNA) which are increasingly recognized as novel potential biomarkers of disease. This study has the main objective of generating reference profiles of both short and long non-coding regulatory exRNA, including environmentally-derived exRNA, from 720 plasma samples collected at the 10-year CARDIA visit. These healthy subjects will be stratified as follows: 180 subjects in each of the following 4 groups: male Caucasian, female Caucasian, male African American, female African American.
Investigator: Iribarren, Carlos
Funder: National Heart, Lung, and Blood Institute
Identifying Opportunities to Lower Rates of and Improve Outcomes after AKI
This multiple-PI proposal leverages our ongoing studies to address the following three aims related to acute kidney injury (AKI): 1) To evaluate the role of patient characteristics and practice variation in accounting for the drop in incidence of AKI observed among hospitalized patients within KPNC; 2) To advance our understanding of the epidemiology of AKI among non-hospitalized patients and how different management strategies in the ambulatory setting correlate with outcomes; and 3) To identify risk factors for recurrent AKI among patients with AKI in the ambulatory or inpatient setting.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Population-Based Epidemiology, Management and Outcomes of Nephrotic Syndrome in Adults and Children: The Kaiser Permanente Nephrotic Syndrome Cohort Study
The aims of this study are to: 1) Assemble a cohort of KPNC adult and pediatric members with nephrotic syndrome and examine temporal trends in the epidemiology of nephrotic syndrome in adults and children between 1996 and 2012, including classification of potential causes. 2) Examine temporal trends in the evaluation and management of nephrotic syndrome in adults and children, overall and in targeted subgroups. 3) Assess predictors of developing nephrotic syndrome in adults and children, overall and by presumptive cause. 4) Characterize the short- and longer-term prognosis of nephrotic syndrome in adults vs. children with regards to renal and cardiovascular outcomes.
Investigator: Go, Alan
Funder: The Brin Wojcicki Foundation
Determinants of Midlife and Longitudinal Change in Cognitive Function: CARDIA Study
This is an ancillary study to the ongoing CARDIA study of 5,115 adults who recently completed their seventh (year 25) follow-up, in which cognitive testing was measured, and will be participating in a year 30 exam in 2015-16. The specific aims are: 1) Using repeated measures collected over 30 years, to determine the association between cardiovascular (CV) risk factors in young adulthood on cognitive function (CF) and 5-year change in CF at mid-life. 2) To determine the association between measures of metabolic regulation, oxidative stress and adiposity in young adulthood on CF and 5-year change in CF at mid-life. 3) To use GWAS data in order to identify novel common and rare genetic variants, particularly on pathways of CV disease and metabolic regulation, associated with CF and decline. 4) To determine if there are race/ethnic difference in the association between risk factors and CF and if so, if they are moderated by socio-economic status, education, literacy and other disparities.
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
NINDS Stroke Trials Network Northern California Regional Coordinating Stroke Center
The primary goal of the NINDS Stroke Trials Network is to maximize efficiencies to develop, promote and conduct high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment, and recovery with the objective to have a balanced portfolio between all three approaches. The aims of the Northern California Regional Coordinating Stroke Center are to: 1) Become a resource to any network PI to plan, initiate and complete a clinical trial in the neurosciences. This will be a joint effort between UCSF and selected medical centers within Kaiser Permanente; and 2) Provide training opportunities to medical students, residents, fellows and faculty within the network to plan and conduct clinical trials.
Investigator: Nguyen-Huynh, Mai
Funder: National Institute of Neurological Disorders and Stroke
Lung Function Decline and Disease Risk from Young Adulthood to Middle Age
This study will take advantage of longitudinal data collection in CARDIA to evaluate the association between lung function and risk of future lung disease and cardiovascular disease. The study will perform spirometry in all CARDIA participants at the year 30 examination, and test the hypothesis that individuals with accelerated decline in lung function are at risk for both pulmonary (COPD) and cardiovascular (hypertension, diastolic heart dysfunction, coronary artery disease, and heart failure) diseases.
Investigator: Iribarren, Carlos
Funder: National Heart, Lung, and Blood Institute
Femur Fracture Outcomes Associated with Bisphosphonate Use
In clinical practice, bisphosphonate drugs are considered one of the main therapies for osteoporosis, based on strong clinical evidence of significant reduction in risk of hip, vertebral and non-vertebral fractures during the first 3-5 years of therapy. However, concerns have emerged regarding uncommon long term adverse outcomes in patients treated beyond this period. This study proposes to fill an important knowledge gap by examining the risk of atypical femur fracture in women who receive bisphosphonate treatment for less than 3 years compared to women who continue treatment beyond 3 years and to examine the association of long term continuation of bisphosphonate therapy and subsequent risk of atypical femur fracture.
Investigator: Lo, Joan
Funder: National Institute on Aging
Retrospective Cohort Study of Risk of Hip Fractures Associated with High Dose, Long-term Proton Pump Inhibitor (HD-PPI) Use or H2 Receptor Antagonists (H2RA) and Cytochrome P450 Pharmacogenomics
This contract agreement with the FDA covers epidemiologic studies of drug safety questions identified by the FDA and led by KP researchers in Northern and Southern California. Examples of current studies include the cardiovascular safety of psychostimulant medications used for treating Attention Deficit Hyperactivity Disorder (ADHD), the effects of bisphosphonate medications on osteonecrosis of the jaw and and cardiac arrhythmias, and the safety of newer combination oral contraceptive agents.
Investigator: Go, Alan
Funder: U.S. Food and Drug Administration
Acute Kidney Injury: A Novel Risk Factor for Cardiovascular Events
This is an ancillary study to the NIDDK-sponsored ASSESS-AKI Study that will conduct complementary analysis from a KPNC retrospective cohort and multi-center prospective cohort to examine whether an episode of acute kidney injury independently increases the risk for clinical cardiovascular events and the potential mechanistic pathways.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Comparative Effectiveness of Catheter Ablation vs Medical Therapy for Atrial Fibrillation
The aims of this study are to examine outcomes associated with receipt of catheter ablation in adults with atrial fibrillation, including procedure-related complications as well as rates of long-term mortality, ischemic stroke, intracranial hemorrhage and hospitalizations. The project will also generate preliminary estimates of the cost-effectiveness of AF ablation incorporating long-term estimates of ischemic stroke, hospitalization and death.
Investigator: Go, Alan
Funder: National Heart, Lung, and Blood Institute
Discovering Healthcare Innovations to Address Disparties in Stroke (DIADS)
Blood pressure control rates are known to differ by race and are likely be an important contributor to racial disparities in stroke, particularly for young African American adults in whom a disturbing increase in stroke rates has occurred in recent years. The DIADS program will provide information that is likely to result in better understanding of stroke etiology in the young and a hypertension (HTN) treatment program that can reduce HTN control disparities and be disseminated widely, resulting in reduction of stroke disparities.
Investigator: Sidney, Stephen
Funder: National Institute of Neurological Disorders and Stroke
Pharmacoepidemiologic Investigations of Safety Related Issues of Marketed Drugs, and Evaluations of Risks Communications and Management Programs
The FDA requires the ability to quantify product risks and test hypotheses based on signals of possible drug safety problems originating from adverse reaction reports received by the FDA, the medical literature, or from other sources. In addition, the FDA needs to evaluate the overall effectiveness of risk management programs as well as those for specific products and for risk management tools currently in use within these programs. The FDA also needs to evaluate the impact and effectiveness of its risk communications in changing behaviors related to the use of FDA-regulated products. Understanding the nature and root causes of medication errors is another area where collaborative research can benefit the FDA in meeting its public health mission.
Investigator: Go, Alan
Funder: U.S. Food and Drug Administration
Lactation and Incidence of Diabetes Mellitus in CARDIA Women
The goals of our study are to prospectively examine whether longer duration of lactation is associated with development of type 2 diabetes in women of reproductive age during the 25-year CARDIA study period (1986-2011) and assess changes in risk factors. We will identify changes in cardiometabolic risk factors and biomarkers linked to incident type 2 DM as well as lactation, and examine duration of lactation for all pregnancies in relation visceral fat levels in mid-life.
Investigator: Gunderson, Erica
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Enhancing Appreciation of the Clinical Significance of Acute Kidney Injury
Our goal is to study outcomes and care processes associated with acute kidney injury. For the ASSESS-AKI portion of the study, the goal is to better delineate the impact of renal function trajectory by comparing different methods of assessing renal function over time, specifically comparing GFR estimated from ASSESS-AKI research data with GFR estimated from Kaiser clinical data on Kaiser subjects enrolled in ASSESS-AKI.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Advancing Geriatrics Infrastructure and Network Growth
This pilot development grant proposes to: 1) evaluate the available information in existing data resources related to multiple morbidity and aging-related variables through collaborations among HCSRN network collaboratives (e.g., CVRN, CRN, SUPREME-DM); 2) pursue up to 3 pilot analyses using existing HCSRN network collaborative project datasets involving issues among older persons with multiple chronic conditions; and 3) convene an annual conference to develop an agenda related to older persons with multiple chronic conditions.
Investigator: Go, Alan
Funder: National Institute on Aging
Prospective Evaluation of Acute Kidney Injury II (PEAK-2)
Renewal of Clinical Research Centers for the prospective ASSESS-AKI Study to extend follow-up of enrolled subjects with and without acute kidney injury.
Investigator: Go, Alan
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Coronary Artery Risk Development in Young Adults (CARDiA)
This landmark 30-year study describes the distribution of coronary heart disease risk factors in a biracial cohort of men and women aged 18 to 30 years at entry; and identifies habits, behaviors and lifestyles that are associated with initial levels of risk factors and with the evolution of risk factors.
Investigator: Sidney, Stephen
Funder: National Heart, Lung, and Blood Institute
