Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

Coronary Disease Clinical Trial

— PERFUSERCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02208388
• Other study ID #: AMCCV2014-06
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2014
• Est. completion date: March 5, 2028

Study information

• Verified date: April 2023
• Source: Asan Medical Center
• Contact: Young-Hak Kim, MD
• Email: mdyhkim[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 5, 2028
• Est. primary completion date: March 5, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Device:
• computed tomography perfusion guided treatment

• Fractional flow reserve guided treatment

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
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	Asan Medical Center	Seoul	Songpa-Gu
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Young-Hak Kim, MD, PhD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Events	All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke	1 year
Secondary	All cause death	All cause death	5 year
Secondary	Myocardial infarction	Myocardial infarction	5 year
Secondary	Target vessel revascularization	Target vessel revascularization	5 year
Secondary	Stent thrombosis	Stent thrombosis	5 year
Secondary	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
Secondary	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
Secondary	Cost effective analysis	Cost effective analysis	1 year