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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Philips Healthcare | INDUSTRY |
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The current study sought to evaluate the clinical relevance of iFR-guided strategy in real world clinical practice using unrestricted study population from stable angina to acute coronary syndrome including acute ST-segment elevation myocardial infarction. Previous abundant historical data of FFR-guided strategy will be also included as historical control to validate the iFR-guided strategy.
In this study, the investigators will validate the clinical relevance of instantaneous wave free ratio (iFR)-guided strategy in real world clinical practice in Korea. The 1,200 patients who underwent iFR measurement will be prospectively enrolled at 5 centers in Republic of Korea. In patients who were indicated revascularization after iFR measurement (iFR<0.90), iFR pullback system (iFR Scout) and post-revascularization iFR measurement will be routinely performed. The primary hypothesis will be tested for non-inferiority of iFR-guided strategy, compared with FFR-guided strategy in terms of 2-year clinical outcomes. For the clinical outcome data following FFR-guided strategy will be used from the pooled data of the DEFER-DES trial, the 3V FFR FRIENDS registry (NCT01621438), and Korean 4-center FFR registry. Using those data, 1200 patients will be selected from the pooled data. In addition, routine application of iFR Scout and post-revascularization iFR measurement will enable us to validate the clinical relevance of iFR-based prediction of acute procedural results and to compare FFR-pullback methods.
Primary Hypothesis: The iFR-guided strategy will be non-inferior regarding patient-oriented composite outcomes (a composite of any death, any MI, any revascularization) at 2-year, compared with FFR-guided strategy.
Primary Outcome:
1] Patient-oriented composite outcome (POCO), defined as a composite of any death, any myocardial infarction (MI) or any revascularization at 2-year after index procedure according to the ARC consensus [2] Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement
Sample Size 1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis enrolled at 5 centers in Republic of Korea.
Inclusion Criteria
①Subject must be ≥18 years
â‘¡ Patients suspected with ischemic heart disease
③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia.
â‘£ Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides
Exclusion criteria
Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg) â‘¡ Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor
Non-cardiac co-morbid conditions are present with life expectancy <2 year (per site investigator's medical judgment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iFR-guied strategy group | 1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent iFR measurement and enrolled at 5 centers in Republic of Korea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instantaneous wave-free ratio measurement | Other | Instantaneous wave-free ratio measurement in order to evaluate functional significance of epicardial stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-oriented composite outcome (POCO) | a composite of any death, any myocardial infarction (MI) or any revascularization according to the ARC consensus | at 2-year after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement | Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement | Immediate after post revascularization |
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Inclusion Criteria:
Subject must be ≥18 years
Patients suspected with ischemic heart disease ③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia.
Exclusion Criteria:
Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg)
Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor â‘¢ Non-cardiac co-morbid conditions are present with life expectancy <2 year (per site investigator's medical judgment).
History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia)
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1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent iFR measurement and enrolled at 5 centers in Republic of Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | Study Chair |
| Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | Study Director |
| Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | South Korea | ||||
| Inje University Ilsan Paik Hospital |
Data will be shared upon request after thorough discussion in steering committee
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| Goyang |
| South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000072657 | ST Elevation Myocardial Infarction |
| D000789 | Angina, Unstable |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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