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Androgens and Subclinical Atherosclerosis in Young Women - Ancillary to CARDIA

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: NCT00037245
Recruitment Status : Completed
First Posted : May 17, 2002
Last Update Posted : February 10, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Washington

Brief Summary:
To examine whether serum androgens, measured earlier in life, and variation in genes related to androgen synthesis, metabolism, and signaling are associated with early-onset subclinical coronary atherosclerosis in young adult women from the community.

Condition or disease
Cardiovascular Diseases Coronary Arteriosclerosis Heart Diseases Polycystic Ovary Syndrome

Detailed Description:


Polycystic ovary syndrome (PCOS) is denoted by hyperandrogenism and symptoms of ovulation dysfunction (e.g., infertility, oligomenorrhea). Women who are diagnosed with PCOS represent the more extreme end of abnormal ovarian function. While PCOS is rare, approximately 20 percent of women are expected to have subclinical polycystic ovaries, identified by sonogram. Factors that are associated with PCOS, insulin resistance and dyslipidemia, are also risk factors for coronary artery disease and there is evidence to suggest that women with PCOS are more likely to experience coronary artery disease. This raises the question: are subclinical cases of polycystic ovaries at increased risk of coronary artery disease?

The study is ancillary to the the Coronary Artery Risk Development in Young Adults (CARDIA) Study, a large cohort study supported by the NHLBI. The CARDIA population provides a unique opportunity to explore these associations because there is a 15-year period of risk factor ascertainment in this population including stored blood + DNA specimens from which serum androgens and relevant genetic markers can be ascertained. In addition, all participants will have coronary artery calcium (CAC) determinations at the year 15 exam. In the ancillary study an additional year 16 visit will occur for the purpose of obtaining a trans vaginal ultrasound determination (TVUS) so as to obtain clinical evidence of hyperandrogenism and look at the joint effects of the clinical evidence and serum markers as predictors of CAC. The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000.


The ancillary study in year 16 of CARDIA will recall 1,200 women who received a coronary artery calcification (CAC) determination in year 15. These women will have an additional blood draw three to 10 days after their last menstrual period, will have a questionnaire administered to them regarding clinical symptoms of PCOS (polycystic ovarian syndrome) and other aspects of hyperandrogenism. Two principal analyses will be performed. The first is a longitudinal analysis using year 2 and year 10 data to use serum markers of hyperandrogenism and genetic markers from DNA samples as predictors of CAC which is defined as present (absent) and is determined at the year 15 examination. The principal method of analysis will be logistic regression. An additional analysis will relate androgen levels at year 2 to lipid levels and other coronary risk factors ascertained at year 2, 7, 10 and 15.

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Study Type : Observational
Study Start Date : September 2001
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
No eligibility criteria

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): NCT00037245

Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: David Siscovick University of Washington

Layout table for additonal information Identifier: NCT00037245    
Other Study ID Numbers: 1144
R01HL065622 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2002    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: December 2005
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease