Reproductive Hormones And Pre-Clinical Cardiovascular Disease (CVD) In Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00574535
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : June 7, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center

Brief Summary:

Heart disease is not just the number one killer of women, it is also a leading cause of disability. While it is generally believed that heart disease in women is a disease of old age, the stark reality is that heart disease is responsible for more deaths than breast cancer AT ALL AGES. Also, when young women develop heart disease, they are more likely to die or become disabled than their male peers. Identifying women at risk for heart disease is an important step toward reducing the impact of this disease.

Although women can develop heart disease at any age, most women show signs and symptoms of disease about 10 years after men. For years, it has been thought that the reason for this lag is that women's hearts are protected by estrogen, and that when women go through menopause and lose their natural estrogen, they also lose their protection from heart disease. It has been assumed that if estrogen is replaced then protection will continue. These assumptions have not been proven. In fact, three large, randomized trials have shown no benefit from hormone replacement therapy in women known to have heart disease, and in fact have shown that hormone replacement may be harmful.

To better understand the role of hormones and heart disease, the investigators propose to look at markers of heart disease in healthy women and compare this to their natural hormone levels. One of the markers known to be related to heart disease is carotid artery intima-medial thickness (c-IMT) which can be measured by creating an ultrasound picture of an artery in the neck. The investgators will use c-IMT scans and serum blood samples from women in the NIH-sponsored Los Angeles Atherosclerosis Study (LAAS), a large epidemiologic study that followed participants for 8 years. The proposed study will use risk factor information, serum samples and c-IMT scans collected from the female participants (about 269 women) over the 8 years of follow-up. The total sample size is 269 subjects, each of whom donated 3 blood specimens for the LAAS study. This research will examine those specimens (800 in total). It will also measure other markers of heart disease, including inflammation (hsCRP) and diabetes (insulin and glucose). All information has been obtained and there will be no need to collect additional information from participants nor additional blood specimens.

Condition or disease
Heart Disease

Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Reproductive Hormones And Pre-Clinical CVD In Women
Study Start Date : January 1995
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Women in LAAS Study

Inclusion Criteria:

  • Healthy
  • Females
  • 40-60 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00574535

United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Noel Bairey-Merz, MD Cedars-Sinai Medical Center

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center Identifier: NCT00574535     History of Changes
Other Study ID Numbers: IRB 4260
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Noel Bairey Merz, Cedars-Sinai Medical Center:
Reproductive Hormones

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