Dynamic Stress Perfusion ct for Detection of Inducible Myocardial Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Myocardial perfusion
研究概览
简要总结
The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients with suspected or known CAD clinically referred for invasive angiography.
详细描述
Rationale: Cardiac computed tomography (CT) provides accurate assessment of the coronary arteries and detects significant coronary stenosis with high diagnostic accuracy. However, the hemodynamic relevance of these stenotic lesion remains unclear, although highly relevant for clinical decision-making. Recent technical developments with third-generation dual-source CT allow to determine myocardial perfusion during hyperemia and thus for assessment of the hemodynamic relevance of coronary lesions using a dynamic acquisition mode. To date, there is only very limited evidence of the feasibility of this approach stemming from single-center studies with varying standards of reference.
Objective: To determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients with suspected or known CAD clinically referred for invasive angiography. In an optional sub-study the diagnostic accuracy of MPICT for the detection of myocardial perfusion defects as determined by cardiac magnetic resonance imaging (CMRI) will be investigated.
Study design: Observational cohort study with fractional flow reserve (FFR) during invasive angiography as the reference standard.
Study population: Patients with known or suspected CAD clinically referred for invasive angiography.
Main study parameters: Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-75 years
- •Stable angina symptoms, suspected or known CAD, and referred for invasive angiography on clinical grounds.
- •Ability to provide informed consent
- •Ability to perform a 20-30 second breath hold
排除标准
- •Hemodynamically and clinically unstable condition (angina at rest, malignant arrhythmias)
- •Prior, documented myocardial infarction, other than (procedure related) minor type II myocardial infarction, which includes Q waves on the ECG or evidence of myocardial infarction on prior non-invasive imaging.
- •Prior stenting or coronary artery bypass graft surgery
- •Significant other cardiovascular conditions affecting the interpretation of MPICT, including, but not limited to: clinical heart failure, IECD (pacemaker/ICD), severe valvular heart disease or prosthetic valves, significant intra-cardiac shunting or other relevant congenital heart disease.
- •eGFR<60 ml/kg/min
- •BMI>30 kg/m2, or weight >120 kg.
- •Atrial fibrillation or other arrhythmia, >6 ectopic beats / min
- •Known or suspected allergy to iodinated contrast medium
- •Pregnancy cannot be excluded
- •Contra-indications for adenosine: bronchial asthma, second or third degree atrioventricular block, blood pressure <110/70 mmHg, allergies or severe side effects in the past.
结局指标
主要结局
Myocardial perfusion
时间窗: For each patient within 4 weeks of the CT perfusion acquisition
invasive fractional flow reserve measurement
次要结局
- Presence of myocardial perfusion defect on MPIMRI(For each patient within 1 week before invasive fractional flow reserve measurement)
- Per patient assessment of hemodynamically significant CAD(For each patient within 4 weeks of the CT perfusion acquisition)
- Coronary stenosis by invasive angiography per territory (branch)(For each patient within 4 weeks of the CT perfusion acquisition)
- Demographics.(For each patient within 1 week before invasive fractional flow reserve measurement)
- Cardiovascular risk factors(For each patient within 1 week before invasive fractional flow reserve measurement)
- 'Image quality, based on the DICOM images measured by experienced readers."(Through study completion, an average of 1 to 2 years)
- Ischemia per standardized myocardial segment(For each patient within 4 weeks of the CT perfusion acquisition)
- Coronary stenosis by CTA per territory (branch)(For each patient within 4 weeks of the CT perfusion acquisition)
研究者
Trialbureau radiology
Dr. K. Nieman MD, PHD
Erasmus Medical Center