Endogenous Estrogen and Coronary Heart Disease in Women

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005446
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: November 2001
  Purpose

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


Condition
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Postmenopause

Study Type: Observational
Study Design: Observational Model: Natural History

Resource links provided by NLM:


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

Study Start Date: April 1994
Estimated Study Completion Date: March 1999
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00005446     History of Changes
Other Study ID Numbers: 4375
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 15, 2014