Endogenous Estrogen and Coronary Heart Disease in Women
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ClinicalTrials.gov Identifier: NCT00005446 |
Recruitment Status
:
Completed
First Posted
: May 26, 2000
Last Update Posted
: December 31, 2015
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Condition or disease |
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Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Postmenopause |
BACKGROUND:
Studies suggest that estrogen replacement therapy (ERT) lowers the risk of coronary heart disease in postmenopausal women. However, it is not known whether higher endogenous levels of estrogens in the postmenopausal period likewise have a protective effect.
DESIGN NARRATIVE:
The study used an existing resource of frozen blood samples from a cohort of 7,058 postmenopausal women enrolled between 1985 and 1991 for a study of endogenous hormones and cancer. The cohort was followed up to identify incident cases of coronary heart disease. One hundred thirty cases of coronary heart disease (defined as nonfatal myocardial infarction or death from coronary heart disease) were expected to occur by the end of follow-up. A nested case-control study was conducted in which each case was matched to two women from the cohort who were the same age as the case, donated blood around the same time, and were alive and free of heart disease as of the date of diagnosis of the case. Frozen serum samples from cases and their matched controls were analyzed for total estradiol, bioavailable estradiol (the estradiol fraction not bound to sex hormone binding globulin) estrone, total cholesterol, and high- and low-density lipoprotein cholesterol. Conditional logistic regression for matched sets were employed to determine whether estrogen levels were lower in the cases than their matched controls. The association between estrogen levels and cholesterol fractions was also investigated.
Study Type : | Observational |
Observational Model: | Case Control |
Time Perspective: | Retrospective |
Study Start Date : | April 1994 |
Actual Primary Completion Date : | March 1999 |
Group/Cohort |
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Postmenopausal women with coronary heart disease |
Postmenopausal women without coronary heart disease
Matched in age to the women with heart disease
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Ages Eligible for Study: | up to 100 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
ClinicalTrials.gov Identifier: | NCT00005446 History of Changes |
Other Study ID Numbers: |
4375 R29HL052123 ( U.S. NIH Grant/Contract ) |
First Posted: | May 26, 2000 Key Record Dates |
Last Update Posted: | December 31, 2015 |
Last Verified: | December 2015 |
Additional relevant MeSH terms:
Cardiovascular Diseases Heart Diseases Coronary Disease Coronary Artery Disease Vascular Diseases Arterial Occlusive Diseases Infarction |
Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Arteriosclerosis |