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

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00574535
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
269
1
179
1.5

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 1995
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Dec 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years to 60 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Healthy

      • Females

      • 40-60 years of age

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Cedars Sinai Medical Center Los Angeles California United States 90048

      Sponsors and Collaborators

      • Cedars-Sinai Medical Center
      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      • Principal Investigator: Noel Bairey-Merz, MD, Cedars-Sinai Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Noel Bairey Merz, Director, Cedars-Sinai Medical Center
      ClinicalTrials.gov Identifier:
      NCT00574535
      Other Study ID Numbers:
      • IRB 4260
      First Posted:
      Dec 17, 2007
      Last Update Posted:
      Apr 23, 2019
      Last Verified:
      Apr 1, 2019
      Individual Participant Data (IPD) Sharing Statement:
      Yes
      Plan to Share IPD:
      Yes
      Keywords provided by Noel Bairey Merz, Director, Cedars-Sinai Medical Center
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Apr 23, 2019