Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women

This study is currently recruiting participants.
Verified May 2013 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00572858
First received: December 12, 2007
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition
Estrogen Deficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • estrogen deficiency of hypothalamic (central brain) origin [ Time Frame: Baseline and Exit Visits ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Blood Hormone draw for FSH, E2; Urine Pregnancy test; Fasting lipid (cholesterol) panel, fasting insulin and fasting blood glucose levels; Reproductive hormones (FSH, LH, E1, E2, bioE2, PO, freeT, SHBG, DHEA-S); Plasma levels of inflammatory and endothelial function markers including but not limited to hsCRP, serum amyloid, endothelin-1, and ELAM; Fasting Salivary Cortisol (stress hormone).


Estimated Enrollment: 75
Study Start Date: January 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Premenopausal Women

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572858

Contacts
Contact: Jo-Ann Eastwood, PhD 310-423-9680 EastwoodJ@cshs.org
Contact: Ying Mou, PhD 3102487669 Ying.Mou@cshs.org

Locations
United States, California
Cedars-Sinai Women's Heart Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ying Mou, PhD    310-248-7669    Ying.Mou@cshs.org   
Principal Investigator: Noel Bairey-Merz, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Noel Bairey-Merz, MD Cedars-Sinai Medical Center
  More Information

Publications:

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00572858     History of Changes
Other Study ID Numbers: IRB 6326
Study First Received: December 12, 2007
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Hypo E

Additional relevant MeSH terms:
Cardiovascular Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014