跳至主要内容
临床试验/NCT01738828
NCT01738828Unknown不适用

Genetic Loci and the Burden of Atherosclerotic Lesions

Global Genomics Group, LLC48 个研究点 分布在 9 个国家目标入组 10,000 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10,000
试验地点
48
主要终点
Genome-Wide Association

研究概览

简要总结

The GLOBAL study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography for assessment of suspected coronary artery disease (CAD).

The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in patients phenotyped using advanced imaging modalities of atherosclerosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Caucasian and of Non-Hispanic or Non-Latino origin
  • Referral for coronary CT angiography to evaluate for presence of CAD
  • The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

排除标准

  • Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding 30 days (except if steroids are administered as pre-medication prior to contrast administration for CT scan within 24 hours).
  • Chemotherapy in the preceding year
  • Major surgery in the preceding 2 months
  • Blood or blood product transfusion in the preceding 2 months
  • Subjects for whom coronary CT angiography is contraindicated per institutional standard of care
  • Subjects with previous coronary arterial revascularization (PCI or CABG)
  • Subjects with atrial fibrillation/flutter or frequent irregular or rapid heart rhythms, which occurred within the past 3 months
  • Subjects with a pacemaker or implantable cardioverter-defibrillator implant
  • Active congestive heart failure or the presence of known non-ischemic cardiomyopathy
  • Known genetic disorders of atherosclerosis, lipid or lipoprotein metabolism

结局指标

主要结局

Genome-Wide Association

时间窗: Baseline

The primary analysis will be a genome-wide association analysis, to determine candidate genes and markers underlying coronary artery disease.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (48)

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