Sex Steroid Hormones and Risk of CHD in Women

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006407
First received: October 12, 2000
Last updated: June 23, 2005
Last verified: March 2005
  Purpose

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).


Condition
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Postmenopause
Coronary Arteriosclerosis

Study Type: Observational
Study Design: Observational Model: Case Control

Resource links provided by NLM:


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

Study Start Date: September 2000
Estimated Study Completion Date: July 2004
Detailed Description:

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 used 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 predicted subsequent risk of coronary heart disease (CHD). A total of 350 case subjects and 350 control subjects were selected from women who were free from cardiovascular disease and cancer at study entry and were not using hormone replacement therapy at baseline. Cases were those women who subsequently developed a documented myocardial infarction or underwent coronary artery revascularization (N=350), while control subjects were selected from study participants who remained free from CHD during follow-up. Controls were matched 1:1 for age, ethnicity, smoking and follow-up time. The study also examined 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 allowed control for confounding.

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006407

Sponsors and Collaborators
Investigators
Investigator: Kathryn Rexrode Brigham and Women's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006407     History of Changes
Other Study ID Numbers: 932
Study First Received: October 12, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014