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Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA

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: NCT00064532
Recruitment Status : Completed
First Posted : July 10, 2003
Last Update Posted : December 3, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kiang Liu, Northwestern University

Brief Summary:
To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.

Condition or disease
Cardiovascular Diseases Atherosclerosis Coronary Arteriosclerosis Coronary Disease Heart Diseases

Detailed Description:


Throughout their lifetime, men are at higher risk of coronary heart disease (CHD) than women, however, after menopause this difference is attenuated. This observation suggests that endogenous sex hormones could be associated with CHD risk. There is some evidence indicating that the effect of sex hormones on CHD risk could be mediated, in part, by alterations in lipid levels or other CHD risk factors. However, other evidence supports an independent relationship of circulating hormone levels with CHD risk.


The study, which is ancillary to MESA, will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3,259 male and 2,802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis (MESA). Subclinical atherosclerosis will be identified using both coronary artery calcium (CAC) and carotid intimal-medial wall thickness (IMT). Progression will be identified by the change in CAC over 3.5 years. Circulating concentrations of total (and free) testosterone (T), dehydroepiandrosterone (DHEA), 17 beta-estradiol (E2), and sex hormone binding globulin (SHBG) in stored serum samples collected at the MESA baseline exam will be assessed. Laboratory results will be merged with existing demographic, anthropometric, lifestyle, CHD risk factor, and subclinical disease data collected in MESA. Cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations. MESA is particularly well suited for disentangling the effects of hormonal factors and CHD risk factors on subclinical atherosclerosis because of the availability of high-quality data, serum samples, and CAC and IMT measurements in a large multi-ethnic population of men and women.

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Study Type : Observational
Actual Enrollment : 6173 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : July 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. Coronary artery calcium [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample of African-American, Chinese-American, Caucasian, and Hispanic residents drawn from six regions in the United States: Baltimore City and Baltimore County, Maryland; Chicago, Illinois; Forsyth County, North Carolina; Los Angeles County, California; New York, New York; and St. Paul, Minnesota.

Exclusion Criteria:

  • Age younger than 45 or older than 84 years
  • Physician-diagnosed heart attack
  • Physician-diagnosed angina or taking nitroglycerin
  • Physician-diagnosed stroke or TIA
  • Physician-diagnosed heart failure
  • Current atrial fibrillation
  • Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)
  • Active treatment for cancer
  • Pregnancy
  • Any serious medical condition which would prevent long-term participation
  • Weight >300 pounds
  • Cognitive inability as judged by the interviewer
  • Living in a nursing home or on the waiting list for a nursing home
  • Plans to leave the community within five years
  • Language barrier (speaks other than English, Spanish, Cantonese or Mandarin)
  • Chest CT scan in the past year

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): NCT00064532

Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Susan Gapstur Northwestern University
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Responsible Party: Kiang Liu, Professor in Preventive Medicine and Geriatrics and Internal Medicine, Northwestern University Identifier: NCT00064532    
Other Study ID Numbers: 1226
R01HL074338 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2003    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: November 2013
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases