CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Blood test +3 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00572858
NCT00572858N/ACompleted

Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women

Cedars-Sinai Medical Center·observational·Posted Dec 13, 2007·Updated Oct 8, 2020

In Brief

An observational study evaluating Blood test, Ultrasound of neck arteries, and 1 other intervention for Estrogen Deficiency. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2007
Enrollment StartJan 1, 2005
Primary CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 15.8 yearsPosted 18.6 years ago

Interventions

Blood testprocedure

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

Blood testgenetic

Blood test for genetic testing

Ultrasound of neck arteriesprocedure

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

Saliva testprocedure

Saliva test for cotisol levels