Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women

NCT00572858 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2020-10-08

No results posted yet for this study

Summary

For unexplained reasons, young premenopausal women with heart disease have twice the rate of death compared to men of the same age. Animal experiments have shown that stress can reduce ovary function in females monkeys due to reductions in brain hormones. This stress and reduced brain hormone levels lead to low estrogen levels and can cause menstrual cycles to become irregular, leading to reductions in fertility. These monkeys are also more likely to develop heart disease. In order, to better understand this relationship the investigators would like to study estrogen levels in premenopausal women with heart disease.

Premenopausal women who have recently undergone a study of their coronary (heart) arteries will have their blood hormone levels measured over one menstrual cycle. The investigators will correlate the blood hormone levels with coronary angiography results and with other markers of heart disease, such as a test that uses noninvasive, painless ultrasound waves to study the thickness of the arteries in the neck (carotid arteries). In addition blood cholesterol levels, blood sugar levels and other blood tests have been shown to correlate with heart disease will be measured.

Another aim of the study is to evaluate a potential link between environmental stress and hormone levels. Each patient will be given multiple questionnaires to evaluate stress, anxiety and depression and the investigators will be measuring the stress hormone (cortisol) levels in saliva for additional information.

The results of the study will further explore a possible link between low estrogen levels and heart disease in young premenopausal women and help pave the way for larger research studies to define better ways of preventing heart disease in these women.

Conditions

  • Estrogen Deficiency

Interventions

PROCEDURE

Blood test

for cholesterol, glucose and insulin levels and levels of various hormones, including but not limited to estrogen

GENETIC

Blood test

Blood test for genetic testing

PROCEDURE

Ultrasound of neck arteries

Non-invasive test using ultrasound waves to measure the thickness of the arteries

PROCEDURE

Saliva test

Saliva test for cotisol levels

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • C.Noel Bairey-Merz, MD · Cedars-Sinai Medical Center

Eligibility

Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572858 on ClinicalTrials.gov