Cardiovascular Diseases Clinical Trial
To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.
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.
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
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