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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
New York University School of Medicine

Study Description
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Brief Summary:
To investigate the relation between endogenous levels of estrogen in postmenopausal women and the subsequent development of coronary heart disease.

Condition or disease
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Postmenopause

Detailed Description:

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 Design
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Study Type : Observational
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : April 1994
Actual Primary Completion Date : March 1999

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Groups and Cohorts
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Group/Cohort
Postmenopausal women with coronary heart disease
Postmenopausal women without coronary heart disease
Matched in age to the women with heart disease


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
Contacts and Locations
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No Contacts or Locations Provided
More Information
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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