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临床试验/NCT00991835
NCT00991835Unknown不适用

Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography

Hiroshima University1 个研究点 分布在 1 个国家目标入组 3,015 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,015
试验地点
1
主要终点
Major cardiac events (Cardiac death and acute coronary syndrome)

研究概览

简要总结

Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • patients with known or suspected coronary artery disease.

排除标准

  • irregular heart beat,
  • known allergy towards the contrast agent,
  • renal dysfunction,
  • uncontrolled heart failure,
  • previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
  • impossible breath-hold, OR
  • end-stage cancer.

结局指标

主要结局

Major cardiac events (Cardiac death and acute coronary syndrome)

时间窗: 2 years after the CT-scan

All-cause death

时间窗: 2 years after the CT-scan

次要结局

  • All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)(2 years after CT-scan)
  • All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)(2 years after the CT-scan)

研究者

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

Yasuki Kihara

Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences

Hiroshima University

研究点 (1)

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