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Estrogen Receptor Variants, HDL, and Atherosclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00081705
First Posted: April 21, 2004
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition
Cardiovascular Diseases Atherosclerosis Coronary Arteriosclerosis Heart Diseases

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: March 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 34 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081705


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: David Herrington Wake Forest University Health Sciences
  More Information

ClinicalTrials.gov Identifier: NCT00081705     History of Changes
Other Study ID Numbers: 1249
R01HL072941 ( U.S. NIH Grant/Contract )
First Submitted: April 19, 2004
First Posted: April 21, 2004
Last Update Posted: July 29, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease