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NCT00572858 · ClinicalTrials.gov registry record
Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- 75
- Enrollment target
NCT00572858: Completed study, sponsored by Cedars-Sinai Medical Center.
NCT00572858 is a clinical trial that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00572858 has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
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.
Primary Outcome
at Baseline and Exit Visits (Baseline visit on day 12-18 of the following menstrual cycle; Final exit visit will be timed 26-33 days from the baseline visit).
Interventions
- PROCEDURE Blood test
- GENETIC Blood test
- PROCEDURE Ultrasound of neck arteries
- PROCEDURE Saliva test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2005-01 |
| Est. Completion | 2020-10 |
What the finished NCT00572858 record still lists
NCT00572858 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Blood test is the first listed.
NCT00572858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00572858 about?
NCT00572858 is a clinical study titled "Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women". 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...
What is the current status of trial NCT00572858?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2005-01. Estimated completion is 2020-10.
What interventions are being tested in trial NCT00572858?
The interventions under investigation include: Blood test (PROCEDURE), Blood test (GENETIC), Ultrasound of neck arteries (PROCEDURE), Saliva test (PROCEDURE).
Who is sponsoring clinical trial NCT00572858?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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