Atherosclerosis |
Arteriosclerosis; Arteriosclerosis/Atherosclerosis |
Clinical Trial: Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA
This study is no longer recruiting patients.
Purpose
To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.
| Condition |
|---|
| Cardiovascular Diseases Atherosclerosis Coronary Arteriosclerosis Coronary Disease Heart Diseases |
MedlinePlus related topics: Coronary Disease; Heart Diseases; Heart Diseases--Prevention; Vascular Diseases
Study Type: Observational
Study Design: Natural History, Defined Population
Study start: July 2003; Study completion: June 2007
BACKGROUND: Throughout their lifetime, men are at higher risk of coronary heart disease (CHD) than women, however, after menopause this difference is attenuated. This observation suggests that endogenous sex hormones could be associated with CHD risk. There is some evidence indicating that the effect of sex hormones on CHD risk could be mediated, in part, by alterations in lipid levels or other CHD risk factors. However, other evidence supports an independent relationship of circulating hormone levels with CHD risk.
DESIGN NARRATIVE: The study, which is ancillary to MESA, will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3,259 male and 2,802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis (MESA). Subclinical atherosclerosis will be identified using both coronary artery calcium (CAC) and carotid intimal-medial wall thickness (IMT). Progression will be identified by the change in CAC over 3.5 years. Circulating concentrations of total (and free) testosterone (T), dehydroepiandrosterone (DHEA), 17 beta-estradiol (E2), and sex hormone binding globulin (SHBG) in stored serum samples collected at the MESA baseline exam will be assessed. Laboratory results will be merged with existing demographic, anthropometric, lifestyle, CHD risk factor, and subclinical disease data collected in MESA. Cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations. MESA is particularly well suited for disentangling the effects of hormonal factors and CHD risk factors on subclinical atherosclerosis because of the availability of high-quality data, serum samples, and CAC and IMT measurements in a large multi-ethnic population of men and women.
Eligibility
Ages Eligible for Study: 45 Years - 85 Years, Genders Eligible for Study: Both
Criteria
Location Information
Susan Gapstur, Northwestern University
More Information
Record last reviewed: December 2004
Last Updated: January 10, 2005
Record first received: July 8, 2003
ClinicalTrials.gov Identifier: NCT00064532
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Not Signed In -


