Observing the natural history of coronary artery disease using FFR measurements
Official title: A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention
Run by CardioVascular Research Foundation, Korea · NCT01366404 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 35 Years and up |
| Sex | All |
| Enrollment | 20000 (estimated) |
| Sponsor | CardioVascular Research Foundation, Korea Academic / other |
| Locations | 29 sites (Anyang and 28 other locations) |
| Status | Recruiting |
| Started | June 2011 |
| Main results expected | April 2037 |
| Study ends | April 2037 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT01366404 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 35 years and older with FFR measurements indicating coronary artery stenosis.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is observational, similar studies using FFR have shown promise in understanding coronary artery disease, indicating potential for valuable insights.
Who can join: the full rules
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 it's running
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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
Show 23 more locations
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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
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.