Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

Study Overview
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Brief Summary
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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

Official Title
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Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: computed tomography perfusion guided treatment
* Device: Fractional flow reserve guided treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computed tomography perfusion<br>Patients with Computed tomography perfusion | Device: computed tomography perfusion guided treatment<br> <br> |
| Active Comparator: Fractional flow reserve<br>Patients with Fractional flow reserve | Device: Fractional flow reserve guided treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Events | All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | All cause death | 5 year | 
| Myocardial infarction | Myocardial infarction | 5 year | 
| Target vessel revascularization | Target vessel revascularization | 5 year | 
| Stent thrombosis | Stent thrombosis | 5 year | 
| Seattle Angina Questionnaire,EQ5D questionnaire | Quality of life score assessed by the EQ-5D-5L The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively. Seattle Angina Questionnaire The Seattle Angina Questionnaire (SAQ) is a vali- dated disease-specific instrument for assessing the health status of patients with coronary artery disease. SAQ scores can be aligned with clinical constructs (eg, scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina) | 5 year | 
| Success of intervention | Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death | 5 year | 
| Cost effective analysis | Cost effective analysis | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed tomography perfusion, Fractional flow reserve