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Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia. However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from patients with stable coronary artery disease.4 FFR may be overestimated and the hemodynamic relevance of a coronary stenosis underestimated in patients with acute coronary syndrome (ACS).Its role in ACS patients still needs to be defined although several studies have recently published addressing the value of FFR-guided PCI in ACS. In fact, recent evidence suggests that culprit lesions of patients presenting with a non-ST-segment elevation myocardial infarction that were deferred based on a "negative" FFR have a relatively high event rate, calling into question the use of FFR in that patient population.
STUDY OBJECTIVE
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional Flow Reserve | Device | Functional assessement of anatomical stenosis of coronary artery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major adverse cardiac events | Rate of the composite of all-cause death, recurrent myocardial infarction | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major adverse cardiac events at 1 year | Rate of composite of all-cause death, recurrent myocardial infarction | 12 months |
| Rate of Ischemic events | Rate of the composite of all-cause death, recurrent myocardial infarction, and any repeat revascularization |
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Inclusion Criteria:
Subject age 19-85 years old
Diagnosed as ACS (unstable angina/ Non ST elevation myocardial infarction, ST elevation myocardial infarction)
Exclusion Criteria:
Severe stenosis with TIMI flow ≤ II of the non-IRA artery
Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI
Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus
Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
⑤ Pregnancy or breast feeding
â‘¥ Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).
⑦ Other primary valvular disease with severe degree: severe mitral regurgitation or mitral stenosis, severe aortic regurgitation or aortic stenosis
â‘§ Patients with a history of Coronary Artery Bypass Graft(CABG)
⑨ Unwillingness or inability to comply with the procedures described in this protocol.
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Patients with acute coronary syndrome and intermediate stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Eun Ho Choo, M.D.,PhD | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Vincent's Hospital | Suwon | Gyeonggido | South Korea | |||
| Uijeongbu St.Mary's Hospital |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 24 months |
| Rate of Death | Rate of All cause death and cardiac death | 24 months |
| Rate of Repeat revascularization | Rate of Any repeat revascularization | 24 months |
| Uijeongbu-si |
| Gyeonggido |
| South Korea |
| Daejeon St.Mary's Hospital | Daejeon | South Korea |
| Incheon St.Mary's Hospital | Incheon | South Korea |
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | South Korea |