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Cardiovascular and Metabolic Conditions Studies

 

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 randomiz...
Funder: National Institute of Neurological Disorders and Stroke
Investigator: Nguyen-Huynh, Mai

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 o...
Funder: National Institute on Aging
Investigator: Lo, Joan

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 t...
Funder: Lexicon Pharmaceuticals, Inc.
Investigator: Ambrosy, Andrew

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 ri...
Funder: National Heart, Lung, and Blood Institute
Investigator: Bhatt, Ankeet

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 ...
Funder: National Heart, Lung, and Blood Institute
Investigator: Gunderson, Erica

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 conte...
Funder: Esperion Therapeutics, Inc.
Investigator: Ambrosy, Andrew

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 lifes...
Funder: GENinCode PLC
Investigator: Iribarren, Carlos

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 we...
Funder: Edwards Lifesciences LLC
Investigator: Ambrosy, Andrew

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 ...
Funder: National Institute on Aging
Investigator: Lo, Joan

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 t...
Funder: National Heart, Lung, and Blood Institute
Investigator: Sidney, Stephen

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.
Funder: Bristol-Myers Squibb Company
Investigator: Go, Alan; Ambrosy, Andrew

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 ...
Funder: National Heart, Lung, and Blood Institute
Investigator: Sidney, Stephen

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 co...
Funder: National Heart, Lung, and Blood Institute
Investigator: Sidney, Stephen

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...
Funder: National Heart, Lung, and Blood Institute
Investigator: Sidney, Stephen

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 sy...
Funder: Northern California Community Benefit Programs
Investigator: Ambrosy, Andrew

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 outpat...
Funder: Janssen AIzheimer Immunotherapy R&D
Investigator: Go, Alan; Ambrosy, Andrew

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...
Funder: Garfield Memorial Fund
Investigator: Nguyen-Huynh, Mai

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 s...
Funder: National Heart, Lung, and Blood Institute
Investigator: Ambrosy, Andrew

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 ute...
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Investigator: Gunderson, Erica

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 h...
Funder: Kaiser Permanente Program Offices
Investigator: Go, Alan; Ambrosy, Andrew

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...
Funder: Gilead Sciences, Inc.
Investigator: Go, Alan; Ambrosy, Andrew

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 fai...
Funder: Abbott Laboratories
Investigator: Ambrosy, Andrew

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.
Funder: Novartis International AG
Investigator: Ambrosy, Andrew

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 red...
Funder: Amarin Corporation
Investigator: Ambrosy, Andrew

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, person...
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Investigator: Gunderson, Erica
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