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临床试验/NCT01393028
NCT01393028终止不适用

Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Erasmus Medical Center4 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2011年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
350
试验地点
4
主要终点
Chest pain

研究概览

简要总结

Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Men and women aged >18 years.
  • Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.

排除标准

  • A history of surgical or percutaneous coronary revascularization
  • Non-revascularized angiographic obstructive coronary artery disease (>50% diameter reduction).
  • Normal invasive coronary angiography or stress imaging less than 1 years ago.
  • Inability or unwillingness to provide informed consent.

研究组 & 干预措施

Cardiac CT

Experimental

Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result

干预措施: Cardiac CT (Other)

Standard care

Other

Standard diagnostic management, including stress testing and/or invasive angiography

干预措施: Standard care (Other)

结局指标

主要结局

Chest pain

时间窗: 1 year

Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up

Class IA Revascularizations

时间窗: 1 year

Number of revascularizations with an ESC class 1A indication

次要结局

  • Cost-effectiveness(1 year)
  • Major adverse cardiovascular events(1 year)
  • Overall medical expenses(1 year)
  • Radiation dose(1 year)
  • Quality of life(1 year)

研究者

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

Koen Nieman

Dr K Nieman

Erasmus Medical Center

研究点 (4)

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