Observing the natural history of coronary artery disease using FFR measurements
A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention
This study is tracking around 20,000 patients with coronary artery disease to see how their condition changes over two years using special heart measurements.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | CardioVascular Research Foundation, Korea Academic / other |
| Locations | 29 sites (Anyang and 28 other locations) |
| Trial ID | NCT01366404 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll approximately 20,000 patients with Fractional Flow Reserve (FFR) measurements to evaluate the natural history of coronary lesions over a two-year period. The study will be conducted at multiple centers across Korea, focusing on clinical and imaging follow-up of participants. By tracking these patients, researchers hope to gain insights into the progression of coronary artery disease and the implications of FFR-guided interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 35 years and older with FFR measurements indicating coronary artery stenosis.
Not a fit: Patients with severe coronary artery conditions, such as TIMI flow less than 3 or those with a life expectancy of less than two years, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of coronary artery disease progression and improve patient management strategies.
How similar studies have performed: While this approach is observational, similar studies using FFR have shown promise in understanding coronary artery disease, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 35 years and older * FFR measurement on one and more coronary artery stenosis * Willing and able to provide informed, written consent Exclusion Criteria: * Stenosis with TIMI\<3 flow * Graft vessel * Ejection fraction \< 30% * Angiographic evidence of extreme tortuosity or calcified coronary vessels * Suspected coronary spasm even after sufficient nitrate injected * Life expectancy \<2 year * Planned cardiac surgery or planned major non cardiac surgery * Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study Imaging study specific exclusion criteria * visually-estimated angiographic reference segment diameter of \<2.75mm or \>4.0mm * Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation
Where this trial is running
Anyang and 28 other locations
- Hallym University Sacred Heart Hospital — Anyang, South Korea (Recruiting)
- Soon Chun Hyang University Hospital Bucheon — Bucheon-si, South Korea (Recruiting)
- Chungbuk National University Hospital — Cheongju-si, South Korea (Recruiting)
- Gangwon National Univ. Hospital — Chuncheon, South Korea (Recruiting)
- Daegu Catholic University Center — Daegu, South Korea (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
- Kyungpook National university hospital — Daegu, South Korea (Recruiting)
- Yeungnam University Medical Center — Daegu, South Korea (Recruiting)
- Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
- The Catholic University of Korea, Deajeon St.Mary's hospital — Daejeon, South Korea (Recruiting)
- Gangneung Asan Hospital — Gangneung, South Korea (Recruiting)
- Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
- Inje University Ilsan Paik Hospital — Ilsan, South Korea (Recruiting)
- Dong-A Medical Center — Pusan, South Korea (Recruiting)
- Pusan National University Hospital — Pusan, South Korea (Recruiting)
- Seoul university Bundang hospital — Seongnam, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
- Hallym University Kangdong Sacred Heart Hospital — Seoul, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
- Kyung-Hee University Hospital at Kangdong — Seoul, South Korea (Recruiting)
- Seoul National University Boramae Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- The Catholic University of Korea, Seoul St.Mary's Hospital — Seoul, South Korea (Recruiting)
- The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul, South Korea (Recruiting)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
- Wonju Severance Christian Hospital — Wŏnju, South Korea (Recruiting)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)
Study contacts
- Principal investigator: Seung-Jung Park, MD,PhD — Asan Medical Center
- Study coordinator: Seung-Jung Park, MD, PhD
- Email: sjpark@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.