Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00064506 |
| Other study ID # |
1224 |
| Secondary ID |
R01HL073366 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2003 |
| Est. completion date |
May 2007 |
Study information
| Verified date |
September 2021 |
| Source |
The University of Texas Health Science Center, Houston |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
