Coronary Artery Disease
Conditions
Keywords
FFR
Brief summary
About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.
Detailed description
This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel failure | 2 year after index FFR measurement |
| composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events | at 2 year after index FFR measurement |
Secondary
| Measure | Time frame |
|---|---|
| Death (all cause and cardiac) | at 2 year after index FFR measurement |
| MI | at 2 year after index FFR measurement |
| Target vessel revascularization | at 2 year after index FFR measurement |
| Target lesion revascularization | at 2 year after index FFR measurement |
| Any re-hospitalization with a cardiac cause | 2 year follow-up after index FFR measurement |
| cardiac death and myocardial infarction | 2 year follow-up after index FFR measurement |
| stented lesion related event including death, myocardial infarction, repeat revascularization | 2 year follow-up after index FFR measurement |
| stroke | 2 year follow-up after index FFR measurement |
| stent thrombosis | 2 year follow-up after index FFR measurement |
| anginal status | 2 year follow-up after index FFR measurement |
| number of anti-anginal medication prescribed | 2 year follow-up after index FFR measurement |
| complication of FFR measurement | 2 year follow-up after index FFR measurement |
| clinical predictors of events | 2 year follow-up after index FFR measurement |
| change in plaque composition (%necrotic core volume) in target segment | 2 year follow-up after index FFR measurement |
| change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography) | 2 year follow-up after index FFR measurement |
| change in total atheroma volume and percent atheroma volume | 2 year follow-up after index FFR measurement |
| change in IVUS-measured MLA | 2 year follow-up after index FFR measurement |
| change in FFR | 2 year follow-up after index FFR measurement |
Countries
South Korea
Contacts
Asan Medical Center