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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005446 |
To investigate the relation between endogenous levels of estrogen in postmenopausal women and the subsequent development of coronary heart disease.
Condition |
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Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Postmenopause |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | April 1994 |
Estimated Study Completion Date: | March 1999 |
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 4375 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005446 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Estrogens Necrosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Disease |
Necrosis Pathologic Processes Cardiovascular Diseases Infarction Myocardial Infarction Coronary Artery Disease |