Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA
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|ClinicalTrials.gov Identifier: NCT00064532|
Recruitment Status : Completed
First Posted : July 10, 2003
Last Update Posted : December 3, 2014
|Condition or disease|
|Cardiovascular Diseases Atherosclerosis Coronary Arteriosclerosis Coronary Disease Heart Diseases|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||6173 participants|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
- Coronary artery calcium [ Time Frame: Baseline ]
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): NCT00064532
|Principal Investigator:||Susan Gapstur||Northwestern University|