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临床试验/NCT00064532
NCT00064532已完成不适用

Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA

Northwestern University0 个研究点目标入组 6,173 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,173
主要终点
Coronary artery calcium

研究概览

简要总结

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

详细描述

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Coronary artery calcium

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kiang Liu

Professor in Preventive Medicine and Geriatrics and Internal Medicine

Northwestern University

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