[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501723":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":47,"responsibleParty":81,"collaborators":84,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":26,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fractional flow reserve-guided PCI","ACTIVE_COMPARATOR","FFR measurement for non-IRA stenosis (\\>50% visual estimation) will be performed by continuous infusion of adenosine (140\\~180 ug\u002Fkg\u002Fmin) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis \\>90%, we will judge FFR value of ≤0.80.",[13],"Diagnostic Test: FFR-guided PCI group",{"label":15,"type":16,"description":17,"interventionNames":18},"Intravascular Ultrasound-guided PCI","EXPERIMENTAL","In IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis. According to pre-defined criteria, the decision of revascularization will be made.\n\nRevascularization criteria in the IVUS-guided PCI group is 1) minimal lumen area (MLA) ≤ 3mm2 or 2) 3mm2 \\\u003C MLA ≤4mm2 and plaque burden \\>70%.",[19],"Diagnostic Test: IVUS-guided PCI group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","IVUS-guided PCI group","In IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"FFR-guided PCI group","In FFR-guided PCI group, FFR measurement for non-IRA stenosis (\\>50% visual estimation) will be performed by continuous infusion of adenosine (140\\~180 ug\u002Fkg\u002Fmin) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis \\>90%, we will judge FFR value of ≤0.80.",[9],[32,35],{"name":33,"affiliation":5,"role":34},"Joo-Yong Hahn, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Young Joon Hong, MD, PhD","Chonnam National University",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Joo Myung Lee, MD, MPH, PhD","CONTACT","82-2-3410-2575","drone80@hanmail.net",{"name":33,"role":41,"phone":45,"phoneExt":26,"email":46},"82-2-3410-3419","jooyong.hahn@gmail.com",[48,67],{"facility":37,"status":49,"city":50,"state":26,"zip":26,"country":51,"countryCode":26,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"NOT_YET_RECRUITING","Gwangju","South Korea",{"type":53,"coordinates":54},"Point",[55,56],126.91556,35.15472,{"lat":56,"lon":55},[59,61,64,65],{"name":36,"role":41,"phone":26,"phoneExt":26,"email":60},"hyj200@hanmail.net",{"name":62,"role":41,"phone":26,"phoneExt":26,"email":63},"Seung Hun Lee, MD, PhD","lsh8602@naver.com",{"name":36,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":62,"role":66,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"facility":5,"status":68,"city":69,"state":26,"zip":26,"country":51,"countryCode":26,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"RECRUITING","Seoul",{"type":53,"coordinates":71},[72,73],126.9784,37.566,{"lat":73,"lon":72},[76,78,79,80],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":77},"drone80@hanmal.net",{"name":33,"role":41,"phone":42,"phoneExt":26,"email":46},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":40,"role":66,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Joo-Yong Hahn","Professor",[85],{"name":37,"class":6},"100501723","ivus-versus-ffr-for-non-infarct-related-artery-lesions-in-patients-with-multivessel-disease-and-acute-mi-100501723",false,"NCT05812963","IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI","Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute Myocardial Infarction","FRAME-AMI2","Inclusion Criteria:\n\n* Subject must be at least 19 years of age\n* Acute ST-segment elevation myocardial infarction (STEMI)\n\n  \\*STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block\n* Acute non-ST-segment elevation myocardial infarction (NSTEMI)\n\n  \\*NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:\n  1. Symptoms of ischemia.\n  2. New or presumed new significant ST-T wave changes\n  3. Development of pathological Q waves on electrocardiography.\n  4. Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.\n  5. Intracoronary thrombus detected on angiography.\n* Successful primary percutaneous coronary intervention (PCI) in \\\u003C 12 h after the onset of symptoms for STEMI patients (In case of NSTEMI, PCI should be performed within 72 hours of symptom onset)\n* Multivessel disease (at least one stenosis of \\>50% in a non-IRA ≥2.25 mm by visual estimation)\n* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he\u002Fshe or his\u002Fher legally authorized representative provides written informed consent prior to any study related procedure.\n\nExclusion Criteria:\n\n* Non-IRA stenosis not amenable for PCI treatment by operators' decision\n* Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI\n* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus\n* Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)\n* Pregnancy or breast feeding\n* Non-cardiac co-morbid conditions are present with life expectancy \\\u003C2 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis\n* Unwillingness or inability to comply with the procedures described in this protocol.","ALL","19 Years",{"count":97,"type":98},1400,"ESTIMATED","INTERVENTIONAL",[101],"NA","The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction (AMI) and multivessel disease.",[104,105],"ST Elevation Myocardial Infarction","Non-ST Elevation Myocardial Infarction",[107,108,109,110,111,105],"ST-segment elevation MI","Fractional flow reserve","intravascular ultrasound","Multivessel disease","Complete revascularization","2024-10-22",{"date":114,"type":115},"2024-10-24","ACTUAL",{"date":117,"type":115},"2023-09-18",{"date":119,"type":98},"2029-12-31",{"name":5,"class":6},2]