Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- Rate of negative invasive angiograms (as percentage of total population)
研究概览
简要总结
Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.
详细描述
Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation.
Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD.
Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD.
Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD.
Study population: 250 patients (>18 yrs) with stable chest complaints, a >10% pre-test probability of CAD, and referred for evaluation of possible CAD.
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
- 否
入选标准
- •Men and women aged >18 years.
- •Chest pain symptoms suspicious of coronary heart disease.
- •Pre-test probability of coronary artery disease >10%
排除标准
- •History of CAD: prior myocardial infarction or revascularization procedure
- •Contra-indication to radiation exposure (CT/SPECT): pregnancy
- •Contra-indication to iodine contrast media: renal failure, iodine allergy
- •Contra-indications to adenosine
- •Inability or unwillingness to provide informed consent.
结局指标
主要结局
Rate of negative invasive angiograms (as percentage of total population)
时间窗: 6 months
Number of performed invasive angiograms with no CAD requiring intervention
次要结局
- Chest pain complaints(6 months)
- Quality of life(6 months)
- Major adverse event rate(6 months)
- Radiation exposure(6 months)
- Number of diagnostic and therapeutic procedures(6 months)
- Medical expenses(6 months)
研究者
Koen Nieman
Dr K Nieman
Erasmus Medical Center