Coronary Disease
Conditions
Keywords
Computed tomography perfusion, Fractional flow reserve
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
Interventions
DEVICEcomputed tomography perfusion guided treatment
DEVICEFractional flow reserve guided treatment
Sponsors
Young-Hak Kim, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Events | 1 year | All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | 5 year | Myocardial infarction |
| Target vessel revascularization | 5 year | Target vessel revascularization |
| Stent thrombosis | 5 year | Stent thrombosis |
| All cause death | 5 year | All cause death |
| 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 |
| Cost effective analysis | 1 year | Cost effective analysis |
| 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) |
Countries
South Korea
Contacts
Primary ContactYoung-Hak Kim, MD
Outcome results
None listed