Recruiting NCT02208388
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: computed tomography perfusion guided treatment, Fractional flow reserve guided treatment.
- Who it may be relevant to
- Registry conditions: Coronary Disease. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve
Overview
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
Interventions
- Device computed tomography perfusion guided treatment
- Device Fractional flow reserve guided treatment
Primary outcome measures
- Composite Events [Time frame: 1 year]
Secondary outcome measures (7)
- All cause death [Time frame: 5 year]
- Myocardial infarction [Time frame: 5 year]
- Target vessel revascularization [Time frame: 5 year]
- Stent thrombosis [Time frame: 5 year]
- Seattle Angina Questionnaire,EQ5D questionnaire [Time frame: 5 year]
- Success of intervention [Time frame: 5 year]
- Cost effective analysis [Time frame: 1 year]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 7 centers
- Asan Medical Center — Seoul
- Hallym University Sacred Heart Hospital — Anyang
- Gangwon National Univ. Hospital — Chuncheon
- Keimyung University Dongsan Medical Center — Daegu
- Pusan National University Hospital — Pusan
- Pusan National University Yangsan Hospital — Pusan
- Severance Hospital — Seoul
Identifiers
NCT: NCT02208388 · AMCCV2014-06