Evaluating heart imaging techniques for coronary disease treatment
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve
This study is testing whether using a specific heart imaging technique called computed tomography perfusion can help people with coronary artery disease get better treatment results compared to another method called fractional flow reserve.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 7 sites (Seoul, Songpa-Gu and 6 other locations) |
| Trial ID | NCT02208388 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of computed tomography perfusion (CTP) guided revascularization compared to fractional flow reserve (FFR) guided revascularization in patients with coronary artery disease. Participants will be evaluated based on their symptoms and the severity of their coronary artery blockages. The study will include patients aged 20 and older who meet specific criteria related to their heart condition and will exclude those with certain severe health issues. The goal is to determine which imaging technique provides better outcomes for patients undergoing treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with diagnosed angina or equivalent symptoms and significant coronary artery stenosis.
Not a fit: Patients requiring surgical procedures or those with severe heart conditions or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with coronary artery disease, enhancing their recovery and quality of life.
How similar studies have performed: Previous studies have shown promising results with similar imaging techniques in guiding coronary interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seoul, Songpa-Gu and 6 other locations
- Asan Medical Center — Seoul, Songpa-Gu, South Korea (Recruiting)
- Hallym University Sacred Heart Hospital — Anyang, South Korea (Completed)
- Gangwon National Univ. Hospital — Chuncheon, South Korea (Completed)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Completed)
- Pusan National University Hospital — Pusan, South Korea (Enrolling_by_invitation)
- Pusan National University Yangsan Hospital — Pusan, South Korea (Completed)
- Severance Hospital — Seoul, South Korea (Withdrawn)
Study contacts
- Principal investigator: Byoung-Wook Choi, MD — Severance Hospital, Yonsei University College of Medicine
- Study coordinator: Young-Hak Kim, MD
- Email: mdyhkim@amc.seoul.kr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.