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Home > "S" Clinical Trials Conditions > Sex Steroid Hormones and Risk of CHD in Women  Sex Steroid Hormones and Risk of CHD in Women
Sex Steroid Hormones and Risk of CHD in Women
For Condition: Postmenopause,Cardiovascular Diseases,Coronary Arteriosclerosis,Heart Diseases,Coronary Disease
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To investigate the relationship between endogenous estrogen and androgen levels and risk of coronary heart disease among postmenopausal women in the Women's Health Initiative-Observational Study (WHI-OS).
Details: BACKGROUND: The role of endogenous gonadal hormones in the etiology of atherosclerotic disease needs clarification. Previous studies of women have been small, rarely prospective, and had other methodological problems. Results have been inconsistent. Observational and clinical trial data on exogenous hormones, also inconsistent, are probably irrelevant to endogenous hormonal effects. On the other hand, despite hormonal differences being evoked as the reason for women having less atherosclerotic disease than men, it is not apparent from existing data that between-person variability in endogenous hormones is likely to be a strong risk factor for atherosclerotic disease in women. Furthermore, the atherosclerotic process begins early in life, and postmenopausal hormone differences are only one aspect of possible hormonal effects on disease. Nevertheless, this study has the potential to provide important new information on the role of endogenous hormones on atherosclerotic disease in postmenopausal women. DESIGN NARRATIVE: The study uses a nested-case control design to measure baseline sex steroid hormone levels (serum total and free estradiol, estrone sulfate, total and free testosterone, dehydroepiandrosterone sulfate) and sex hormone binding globulin to determine whether these predict subsequent risk of coronary heart disease (CHD). A total of 350 case subjects and 350 control subjects are selected from women who were free from cardiovascular disease and cancer at study entry and were not using hormone replacement therapy at baseline. Cases are those women who subsequently developed a documented myocardial infarction or underwent coronary artery revascularization (N=350), while control subjects are selected from study participants who remained free from CHD during follow-up. Controls are matched 1:1 for age, ethnicity, smoking and follow-up time. The study also examines correlations between sex steroid hormone levels and other previously funded analyses of biomarkers, including thrombotic and inflammatory markers, lipoproteins, fasting glucose and insulin. Detailed baseline data including anthropometrics and behavioral factors allow control for confounding.
Eligibility:
Study Type: Observational, Natural History, Case Control
Minimum Age/Maximum Age: 50 Years/79 Years
Genders: Female
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KathrynRexrode, , Brigham and Women's Hospital
Additional Information:
Study ID Numbers: 932;
Study Start Date: September 2000
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006407
Other Postmenopause Studies:
1. Plasma Homocysteine Distribution in the United States
2. High Blood Pressure in the Young
3. Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause
4. Statistical Analysis of Pediatric Task Force Data Base
5. Epidemiology of Decline in Heart Disease Mortality
Related Studies:
Other Postmenopause Clinical Trials
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Sex Steroid Hormones and Risk of CHD in Women
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