Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

Not Applicable

Recruiting

• Conditions: Coronary Disease
• Interventions: Device: Fractional flow reserve guided treatment; Device: computed tomography perfusion guided treatment

• Registration Number: NCT02208388
• Lead Sponsor: Young-Hak Kim, MD, PhD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-08-03
• Study First Posted: 2014-08-05
• Study Start: 2014-08-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05
• Primary Completion: 2028-03-05
• Study Completion: 2028-03-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional flow reserve	Fractional flow reserve guided treatment	Patients with Fractional flow reserve
Computed tomography perfusion	computed tomography perfusion guided treatment	Patients with Computed tomography perfusion

Primary Outcome Measures

Name	Time	Method
Composite Events	1 year	All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke

Secondary Outcome Measures

Name	Time	Method
All cause death	5 year	All cause death
Myocardial infarction	5 year	Myocardial infarction
Target vessel revascularization	5 year	Target vessel revascularization
Seattle Angina Questionnaire,EQ5D questionnaire	5 year	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)
Success of intervention	5 year	Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Stent thrombosis	5 year	Stent thrombosis
Cost effective analysis	1 year	Cost effective analysis

Trial Locations

Locations (7)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Pusan, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of