Estrogen Deficiency and Cardiovascular Disease in Premenopausal Women

NCT00572858 | Completed DMC

• 1 other identifier: IRB 6326
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypo E

Outcome Measures

Primary Outcomes (1)

• estrogen deficiency of hypothalamic (central brain) origin

  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).

  51 days

Study Arms (1)

Premenopausal women

Female patients who have undergone coronary angiography and are under the age of 55

Procedure: Blood test; Genetic: Blood test; Procedure: Ultrasound of neck arteries; Procedure: Saliva test

Interventions

Blood test PROCEDURE

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

Premenopausal women

Ultrasound of neck arteries PROCEDURE

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

Premenopausal women

Saliva test PROCEDURE

Saliva test for cotisol levels

Premenopausal women

Eligibility Criteria

• Age: Up to 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal Women

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Location

Related Publications (8)

• Demissie S, Cupples LA, Shearman AM, Gruenthal KM, Peter I, Schmid CH, Karas RH, Housman DE, Mendelsohn ME, Ordovas JM. Estrogen receptor-alpha variants are associated with lipoprotein size distribution and particle levels in women: the Framingham Heart Study. Atherosclerosis. 2006 Mar;185(1):210-8. doi: 10.1016/j.atherosclerosis.2005.06.008. Epub 2005 Jul 7.

  PMID: 16005459 BACKGROUND

• Gold B, Kalush F, Bergeron J, Scott K, Mitra N, Wilson K, Ellis N, Huang H, Chen M, Lippert R, Halldorsson BV, Woodworth B, White T, Clark AG, Parl FF, Broder S, Dean M, Offit K. Estrogen receptor genotypes and haplotypes associated with breast cancer risk. Cancer Res. 2004 Dec 15;64(24):8891-900. doi: 10.1158/0008-5472.CAN-04-1256.

  PMID: 15604249 BACKGROUND

• Herrington DM, Howard TD. ER-alpha variants and the cardiovascular effects of hormone replacement therapy. Pharmacogenomics. 2003 May;4(3):269-77. doi: 10.1517/phgs.4.3.269.22686.

  PMID: 12718718 BACKGROUND

• Schuit SC, de Jong FH, Stolk L, Koek WN, van Meurs JB, Schoofs MW, Zillikens MC, Hofman A, van Leeuwen JP, Pols HA, Uitterlinden AG. Estrogen receptor alpha gene polymorphisms are associated with estradiol levels in postmenopausal women. Eur J Endocrinol. 2005 Aug;153(2):327-34. doi: 10.1530/eje.1.01973.

  PMID: 16061840 BACKGROUND

• Schuit SC, Oei HH, Witteman JC, Geurts van Kessel CH, van Meurs JB, Nijhuis RL, van Leeuwen JP, de Jong FH, Zillikens MC, Hofman A, Pols HA, Uitterlinden AG. Estrogen receptor alpha gene polymorphisms and risk of myocardial infarction. JAMA. 2004 Jun 23;291(24):2969-77. doi: 10.1001/jama.291.24.2969.

  PMID: 15213208 BACKGROUND

• Schuit SC, van der Klift M, Weel AE, de Laet CE, Burger H, Seeman E, Hofman A, Uitterlinden AG, van Leeuwen JP, Pols HA. Fracture incidence and association with bone mineral density in elderly men and women: the Rotterdam Study. Bone. 2004 Jan;34(1):195-202. doi: 10.1016/j.bone.2003.10.001.

  PMID: 14751578 BACKGROUND

• Shearman AM, Cupples LA, Demissie S, Peter I, Schmid CH, Karas RH, Mendelsohn ME, Housman DE, Levy D. Association between estrogen receptor alpha gene variation and cardiovascular disease. JAMA. 2003 Nov 5;290(17):2263-70. doi: 10.1001/jama.290.17.2263.

  PMID: 14600184 BACKGROUND

• Shearman AM, Demissie S, Cupples LA, Peter I, Schmid CH, Ordovas JM, Mendelsohn ME, Housman DE. Tobacco smoking, estrogen receptor alpha gene variation and small low density lipoprotein level. Hum Mol Genet. 2005 Aug 15;14(16):2405-13. doi: 10.1093/hmg/ddi242. Epub 2005 Jul 13.

  PMID: 16014638 BACKGROUND

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).

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• C.Noel Bairey-Merz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2005
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)