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Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kiang Liu, Northwestern University Identifier:
First received: July 8, 2003
Last updated: December 2, 2014
Last verified: November 2013
To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.

Cardiovascular Diseases Atherosclerosis Coronary Arteriosclerosis Coronary Disease Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:

Further study details as provided by Kiang Liu, Northwestern University:

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

Enrollment: 6173
Study Start Date: July 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   45 Years to 84 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00064532

Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Susan Gapstur Northwestern University
  More Information

Responsible Party: Kiang Liu, Professor in Preventive Medicine and Geriatrics and Internal Medicine, Northwestern University Identifier: NCT00064532     History of Changes
Other Study ID Numbers: 1226
R01HL074338 ( U.S. NIH Grant/Contract )
Study First Received: July 8, 2003
Last Updated: December 2, 2014

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases processed this record on August 21, 2017