Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial (PERFUSERCT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Disease
• Intervention / Treatment: Device: computed tomography perfusion guided treatment; Device: Fractional flow reserve guided treatment

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Completed
    • Hallym University Sacred Heart Hospital
  • Chuncheon, Korea, Republic of
    • Completed
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Completed
    • Keimyung University Dongsan Medical Center
  • Pusan, Korea, Republic of
    • Enrolling by invitation
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Completed
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of
    • Withdrawn
    • Severance Hospital
  • Songpa-Gu
    • Seoul, Songpa-Gu, Korea, Republic of
      • Recruiting
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computed tomography perfusion; Patients with Computed tomography perfusion	Device: computed tomography perfusion guided treatment
Active Comparator: Fractional flow reserve; Patients with Fractional flow reserve	Device: Fractional flow reserve guided treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Young-Hak Kim, MD, PhD

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2014
• Primary Completion (Anticipated): March 5, 2028
• Study Completion (Anticipated): March 5, 2028

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 3, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Fractional flow reserve; Computed tomography perfusion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: AMCCV2014-06