A Head-to-Head Prospective Comparison of Diagnostic Accuracy of CCTA and Dynamic CT Perfusion in Patients With Prior PCI for the Diagnosis of Myocardial Ischemia as Defined by Invasive Flow and Pressure Indices - PACIFIC-III
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of Dynamic CT-perfusion and CCTA for CAD
研究概览
简要总结
A single centre prospective trial in which patients with a prior PCI for stable CAD who are referred for invasive angiography will undergo state-of-the art CCTA and dynamic CT perfusion. Subsequently invasive FFR and iFR measurements will be routinely performed in each coronary vessel.
详细描述
Rationale: Recent development in computed tomography (CT) hardware have fulfilled the prerequisites for clinical CT myocardial perfusion imaging (CTP). Cardiac CT, has by means of coronary computed tomography angiography (CCTA) and novel techniques such as CTP the unique ability to provide information on both the anatomical and functional severity of coronary artery disease (CAD). However, diagnostic performance of these novel techniques when referenced by the clinical diagnostic standard, invasive fractional flow reserve (FFR) measurements, has scarcely been investigated in patients with a prior PCI.
Objective: To determine the diagnostic performance of CCTA and dynamic CTP for the diagnosis of myocardial ischemia using invasive coronary indices as the reference standard.
Study design: The study is a single-center prospective comparative trial in which all patients will undergo CCTA and dynamic CTP before invasive coronary angiography (ICA) in conjunction with invasive flow/pressure measurements.
Study population: Patients referred for a diagnostic ICA with a prior of PCI for stable CAD will be evaluated for inclusion in the study.
Main study parameters/endpoints: Hemodynamic significant CAD as defined by an FFR ≤0.80 / iFR < 0.90. Sensitivity, specificity, negative predictive value, positive predictive value and accuracy will be assessed for CCTA and dynamic CTP. In addition, this study will assess the prognostic value of CCTA and dynamic CTP in patients with a prior cardiac revascularization.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of PCI for stable CAD
- •Referred for a diagnostic ICA.
- •Age above 30 years.
排除标准
- •History of severe COPD or chronic asthma
- •Pregnancy
- •Renal failure (eGFR <30 mL/min)
- •Use of sildenafil (Viagra) or dipyramidol (Persantin) that cannot be terminated
- •Contra-indications for β-blockers
- •Allergic reaction to iodized contrast
- •Concurrent or prior (within last 30 days) participation in other research studies using investigational drugs
- •Claustrophobia
- •Significant co-morbidities
- •Atrial fibrillation, second or third degree atrioventricular block
- •Tachycardia
- •Acute myocardial infarction
- •History of CABG
- •Heart failure
- •Cardiomyopathies
- •Previous radiation exposure in the diagnostic work-up
- •Unable to give informed consent
- •Indispensable follow-up with (serial) CT scans for non-cardiac related condition
结局指标
主要结局
Sensitivity and Specificity of Dynamic CT-perfusion and CCTA for CAD
时间窗: 3 years
FFR will be used as a reference standard, the primary endpoint is an abnormal FFR =\< 0.80. Diagnostic study using FFR as endpoun
次要结局
- Major adverse cardiac events, cardiac death or repeat revascularization(3 years)
研究者
Ibrahim Danad, MD
Principal Investigator
Amsterdam UMC, location VUmc