Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women

Completed

Conditions studied: Estrogen Deficiency

In brief

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.

Key facts

Study ID

NCT00572858

Run by

Cedars-Sinai Medical Center

People needed

75

Starts

2005-01-01

Expected to finish

2020-10-01

Last updated by the study team

2020-10-08

Who can join

Age: any, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Premenopausal by WISE criteria
• English speaking (for the purposes of complete psychosocial assessment)
• Able to give informed consent
• Clinically-indicated coronary angiography within the last 24 months prior to enrollment with no interim change in symptoms, hospitalization, or events.
• Non-English speaking patients will be consented but will not undergo psychosocial assessment as part of the study.

You may not qualify if…

• Pregnant or intention of becoming pregnant during study period.
• Current hormonal therapy (oral contraceptives, hormone replacement therapy, designer estrogens or phytoestrogens)
• History of bilateral salpingoophorectomy

Where it is running

• Cedars-Sinai Women's Heart Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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