Clinical trial NCT02208388: Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial
Official title: Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Disease
Keywords: Computed tomography perfusion
Fractional flow reserve
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Composite Events
timeFrame: 1 year
Secondary outcomes:
measure: All cause death
timeFrame: 5 year
measure: Myocardial infarction
timeFrame: 5 year
measure: Target vessel revascularization
timeFrame: 5 year
measure: Stent thrombosis
timeFrame: 5 year
measure: Seattle Angina Questionnaire,EQ5D questionnaire
timeFrame: 5 year
measure: Success of intervention
timeFrame: 5 year
measure: Cost effective analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital, Yonsei University College of Medicine
name: Byoung-Wook Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Young-Hak Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: