Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00081705 |
| Other study ID # |
1249 |
| Secondary ID |
R01HL072941 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 19, 2004 |
| Last updated |
July 28, 2016 |
| Start date |
March 2004 |
| Est. completion date |
February 2007 |
Study information
| Verified date |
January 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To measure the association between estrogen receptor variants and the extent of
atherosclerosis in the thoracic and abdominal aorta and the right coronary artery in
subjects in the PDAY study.
Description:
BACKGROUND:
Increased levels of HDL cholesterol are associated with lower rates of clinical and anatomic
atherosclerosis, even in adolescents and young adults. In premenopausal women,
estrogen-associated increases in HDL may account for their low rates of coronary heart
disease (CHD) events. Recently, a sequence variant in the estrogen receptor-alpha (ER-alpha)
gene, ER-alpha IVS1-397 T/C), has been linked to twofold greater increases in HDL
cholesterol in response to hormone replacement therapy (HRT). However, it remains unclear
whether this sequence variant also augments HDL levels in the setting of premenopausal
estrogen exposure and whether such differences translate into greater reductions in
atherosclerosis risk. The study uses the cohort of the Pathobiology of Atherosclerosis in
Youth (PDAY) study, a large cross-sectional autopsy study of the extent of atherosclerosis
in subjects aged 15 to 34 years. The detailed descriptions of atherosclerotic lesions,
combined with data on cardiovascular risk factors and access to tissue for DNA extraction,
makes this an ideal cohort in which to examine the association between ER-alpha IVS1-397
genotypes, HDL levels, and development of early atherosclerosis.
DESIGN NARRATIVE:
The overall goal for this study is to measure the association between the estrogen receptor
(ER- IVS1-401 T/C) polymorphism and extent of abdominal aorta, thoracic artery, and right
coronary artery atherosclerosis in Pathobiological Determinants of Atherosclerosis in Youth
(PDAY) subjects. The investigators will use DNA extracted from liver specimens in order to
measure the ER polymorphisms. The extent of atherosclerosis will be defined as the percent
of intimal area involved with fatty streaks or raised lesions, using previously established
PDAY definitions. However, percent involvement of fatty streaks alone and the percent
involvement of the individual components of raised lesions (fibrous plaques, complicated
lesions, and calcified lesions) will be analyzed separately. Available data on risk factors
(smoking, diabetes, hyperlipidemia, hypertension) will permit reducing confounding of the
results by allowing adjustments for effects of the major risk factors for coronary heart
disease. The Department of Pathology at Louisiana State University Health Sciences Center
(LSUHSC) has been designated by the National Heart, Lung and Blood Institute to centralize,
maintain, and distribute the valuable material collected through the combined efforts of the
cooperating institutions for further studies in atherosclerosis. LSUHSC will provide DNA for
polymorphism analysis and assist in data analysis. Polymorphism determination will occur at
Wake Forest.
