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NCT00005446 Clinical Trial

Endogenous Estrogen and Coronary Heart Disease in Women

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005446
Other study ID # 4375
Secondary ID R29HL052123
Status Completed
Phase N/A
First received May 25, 2000
Last updated December 30, 2015
Start date April 1994

Study information
Verified date December 2015
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To investigate the relation between endogenous levels of estrogen in postmenopausal women and the subsequent development of coronary heart disease.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date March 1999
Accepts healthy volunteers No
Gender Female
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
New York University School of Medicine National Heart, Lung, and Blood Institute (NHLBI)
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