Gene-Environment Interactions in Complex Disease

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

To assess genetic variation in 87 different cardiovascular disease candidate genes and to measure the associations of these variants with cardiovascular disease and its risk factors.

Condition or disease
Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease

Detailed Description:

BACKGROUND:

Cardiovascular disease (CVD), the number one cause of death in industrialized countries today is a complex disease with a multifactorial etiology involving many genetic and environmental factors. Public health prevention programs designed to reduce the risk and occurrence of CVD commonly focus on modifiable environments and behaviors such as diet and physical activity, with varied results among individuals. This heterogeneity in response to CVD interventions is at least in part of genetic origin. Although a number of candidate genes have been identified which appear to influence the development of CVD, little is known about how these genetic effects may vary within demographic (e.g., race and gender) and environmental (e.g., diet and exercise) contexts; thus, it is of utmost importance to determine how genes and environments interact to produce CVD.

DESIGN NARRATIVE:

The purpose of this study is to characterize the environment-dependent effects of 87 biologic and positional candidate genes in a population-based sample of 11,625 African-American and Caucasian men and women from the Atherosclerosis Risk in Communities (ARIC) study. Candidate loci were selected based on confirmed functional significance, consistent association with CVD or its risk factors, and or identified as positional candidates in genome-wide linkage scans. Environmental contexts will focus on dietary measures (e.g., total kcals, Keys score, alcohol intake), obesity, measures of physical activity (sport, leisure, and work indices), smoking, and menopause status/hormone use (women only). Outcome variables will include measures of quantitative risk factors (e.g., total cholesterol, BMI, blood pressure), subclinical disease (carotid wall thickness), and clinical disease (incident coronary heart disease (CHD) and stroke). Existing DNA samples will be used for genotyping of candidate loci, and no further contact with study participants will be necessary. The ARIC cohort, because of its large size and wealth of environmental and physiological measures, provides an ideal, timely, and efficient opportunity to evaluate the effects of modifiable environments on genetic variation which may influence CVD risk and disease outcomes with the ultimate goal of establishing more efficacious programs for the treatment and prevention of CVD.

Study Design

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Study Type :	Observational
Actual Enrollment :	15792 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Gene-Environment Interactions in Complex Disease
Study Start Date :	July 2003
Actual Primary Completion Date :	May 2007
Actual Study Completion Date :	May 2007

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Subjects aged 14-65 from four communities.

Criteria

No eligibility criteria

Contacts and Locations

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Sponsors and Collaborators

The University of Texas Health Science Center, Houston

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Eric Boerwinkle	University of Texas

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Hsu CC, Kao WH, Coresh J, Pankow JS, Marsh-Manzi J, Boerwinkle E, Bray MS. Apolipoprotein E and progression of chronic kidney disease. JAMA. 2005 Jun 15;293(23):2892-9.

Responsible Party:	Eric Boerwinkle, ◦Professor & Director, Division of Epidemiology & Kozmetsky Family Chair In Human Genetics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00064506 History of Changes
Other Study ID Numbers:	1224; R01HL073366 ( U.S. NIH Grant/Contract )
First Posted:	July 10, 2003
Last Update Posted:	January 15, 2015
Last Verified:	January 2015

Additional relevant MeSH terms:

Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease	Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Ischemia