Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
- Conditions
- Multivessel Coronary Artery Disease
- Registration Number
- NCT01621438
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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).
* Comparison of clinical outcomes of deferred lesions according to iFR and FFR values β₯ Prognosis of functional complete revascularization versus incomplete revascularization
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1136
- Subject must be at least 18 years of age.
- Subject must have stenosis (>30% by visual estimate) in all 3-epicardial coronary arteries.
- FFR should be measured at all 3-vessels at the end of a procedure.
- Depressed left ventricular systolic function (ejection fraction < 35%)
- ST-elevation myocardial infarction within 72 hours,
- Prior coronary artery bypass graft surgery
- Creatinine level >= 2.0mg/dL or dependence on dialysis
- Abnormal final myocardial flow (TIMI flow < 3)
- Planned bypass surgery
- Failed FFR measurement
- Failed intended revascularization
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR 2 years after FFR measurement
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Aichi Medical university hospital
π―π΅Nagakute, Japan
Tokyo medical college hospital
π―π΅Tokyo, Japan
Wakayama medical university
π―π΅Wakayama, Japan
Fuwai hospital
π¨π³Beijing, China
Gifu heart center
π―π΅Gifu, Japan
National Taiwan University hospital
π¨π³Taipei city, Taiwan
Guandong general hospital
π¨π³Guandong, China
Zhejiang No 2 hospital
π¨π³Zhejiang, China
Kokura memorial hospital
π―π΅Kita-Kyushu, Japan
Queen Mary Hospital, The University of Hong Kong
π¨π³Hong Kong, China
Keimyung University Dongsan medical center
π°π·Daegu, Korea, Republic of
National University Heart center
πΈπ¬Singapore, Singapore
Inje university Ilsan Paik hospital
π°π·Ilsan, Korea, Republic of
2nd Red Cross hospital
π―π΅Kyoto, Japan
Samsung Medical Center
π°π·Seoul, Korea, Republic of
Ajou university hospital
π°π·Suwon, Korea, Republic of
Ulsan university hospital
π°π·Ulsan, Korea, Republic of
Seoul National University Hospital, Seoul, Korea
π°π·Seoul, Korea, Republic of
United Christian Hospital
π¨π³Hong Kong, China
Nanjing 1st hospital
π¨π³Nanjing, China