NCT02208388招募中不适用
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve
Young-Hak Kim, MD, PhD7 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年8月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Composite Events
研究概览
简要总结
The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 and more
- •Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
- •Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
- •70 % stenosis or more in coronary CTA
- •Willing to provide informed, written consent
排除标准
- •Requirement for surgical procedure
- •Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- •Recent STEMI (<5 days)
- •Non STEMI, if the cardiac troponin is not stable or starting to decline
- •Left ventricular ejection fraction <30%
- •Life expectancy <2 years
- •Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL
- •Undergoing evaluation for organ transplantation
- •Participation or planned participation in another cardiovascular clinical trial
- •Pregnancy
- •Inability to take dual antiplatelet therapy for six months
- •Previous CABG
- •Left main disease requiring revascularization
- •Any target lesion with in-stent restenosis
- •NYHA class 3 or 4a
- •Severe and persistent angina with severe limitation in everyday living activities (Canadian Cardiovascular Society grading Class IV)
结局指标
主要结局
Composite Events
时间窗: 1 year
All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke
次要结局
- Myocardial infarction(5 year)
- Target vessel revascularization(5 year)
- All cause death(5 year)
- Seattle Angina Questionnaire,EQ5D questionnaire(5 year)
- Success of intervention(5 year)
- Stent thrombosis(5 year)
- Cost effective analysis(1 year)
研究者
Young-Hak Kim, MD, PhD
MD
Asan Medical Center
研究点 (7)
Loading locations...
相似试验
已完成
不适用
Perfusion CT RegistryCoronary Artery DiseaseNCT01696006Young-Hak Kim, MD, PhD1,059
终止
不适用
Computed Tomography (CT) Perfusion Imaging of Lung CancerCarcinoma, Non Small Cell LungNCT00905801University of Pittsburgh16
终止
不适用
CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic CancerPancreatic Ductal AdenocarcinomaNCT03012282University of Washington70
已完成
不适用
Special Imaging Technique to Aid in the Diagnosis of Patients in Coma After Cardiac ArrestBrain DeathNCT02102945Nova Scotia Health Authority5
撤回
不适用
BELgian CT-perFUSion Study to Select Acute Stroke Patients for ThrombectomyStrokeStroke, AcuteStroke, IschemicNCT05685043University Hospital, Ghent