Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.
Multivessel Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease|
- The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR [ Time Frame: 2 years after FFR measurement ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||September 2016|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed.
Pre-specified Subgroup Analysis
The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects:
Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.).
Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed).
Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test.
- Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR <0.75, 0.75-0.80, and >0.80).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621438
|Guandong general hospital|
|Queen Mary Hospital, The University of Hong Kong|
|Hong Kong, China|
|United Christian Hospital|
|Hong Kong, China|
|Nanjing 1st hospital|
|Zhejiang No 2 hospital|
|Gifu heart center|
|Kokura memorial hospital|
|2nd Red Cross hospital|
|Aichi Medical university hospital|
|Tokyo medical college hospital|
|Wakayama medical university|
|Korea, Republic of|
|Keimyung University Dongsan medical center|
|Daegu, Korea, Republic of|
|Inje university Ilsan Paik hospital|
|Ilsan, Korea, Republic of|
|Seoul National University Hospital, Seoul, Korea|
|Seoul, Korea, Republic of|
|Ajou university hospital|
|Suwon, Korea, Republic of|
|Ulsan university hospital|
|Ulsan, Korea, Republic of|
|National University Heart center|
|National Taiwan University hospital|
|Taipei city, Taiwan|
|Principal Investigator:||Bon-Kwon Koo, MD||Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea|