Time for a Diagnostic Paradigm Shift From STEMI/NSTEMI to OMI/NOMI
NCT Number: NCT06570759
Acronym: DIFOCCULT-3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myocardial Infarction|Myocardial Ischemia|Acute Coronary Syndrome|Diagnosis|Morality
Interventions: PROCEDURE: Early intervention for OMI|PROCEDURE: Standard early intervention for STEMI|PROCEDURE: Standard delayed intervention for NSTEMI
Sponsor: Başakşehir Çam & Sakura City Hospital
Collaborators: Ankara Etlik City Hospital|Antalya City Hospital|Bağcılar Training and Research Hospital|Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital|Ataturk University|Eskisehir City Hospital|Kartal Kosuyolu High Speciality Training and Research Hospital|Marmara University Pendik Training and Research Hospital|Istanbul Mehmet Akif Ersoy Educational and Training Hospital|Muğla Sıtkı Koçman University|Necmettin Erbakan University, Meram Faculty of Medicine|Ordu State Hospital|Sanliurfa Mehmet Akif Inan Education and Research Hospital|Sirnak State Hospital|Tokat Gaziosmanpasa University|Umraniye Education and Research Hospital|Van Training and Research Hospital|Yuzuncu Yıl University|Kutahya Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2026-10-01
Locations: Ankara Etlik City Hospital, Ankara, 6010, Turkey|Antalya City Hospital, Antalya, 07080, Turkey|Erzurum Atatürk University Hospital, Erzurum, 25040, Turkey|Eskişehir City Hospital, Eskişehir, 26080, Turkey|Mehmet Akif Ersoy Cardiovascular and Throacic Training and Research Hospital, Istanbul, 34303, Turkey|Basaksehir Cam and Sakura City Hospital, Istanbul, 3440, Turkey|Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, 34668, Turkey|Umraniye Training and Research Hospital, Istanbul, 34764, Turkey|Kartal Kosuyolu Training and Research Hospital, Istanbul, 34865, Turkey|Marmara University, Pendik Training and Research Hospital, Istanbul, 34899, Turkey|Bağcılar Training and Research Hospital, Istanbul, Turkey|Necmettin Erbakan Meram Tıp Fakültesi Hastanesi, Konya, 42080, Turkey|Kutahya Health Sciences University, Kütahya, 43020, Turkey|Mugla Sitki Kocman University, Muğla, 48000, Turkey|Ordu State Hospital, Ordu, 52200, Turkey|Tokat Gaziosmanpaşa University, Tokat, 60030, Turkey|Yuzuncu Yil University Hospital, Van, 65080, Turkey|Van Training and Research Hospital, Van, 65300, Turkey|Sanliurfa Mehmet Akif İnan Training and Research Hospital, Şanlıurfa, 63320, Turkey|Sirnak State Hospital, Şırnak, 73000, Turkey

Summary:
The investigators hypothesize that occlusion myocardial infarction(MI)/non-occlusion MI approach to MI treatment will better predict acute coronary occlusion on coronary angiography, better limit infarct size, better preserve left ventricular function and result in lower long-term adverse cardiac events (all cause mortality, all cause rehospitalization) compared to standard ST-elevation/non-ST-elevation MI paradigm.

Primary Outcome Measures: Primary end point: Major adverse events (Mortality and rehospitalization), The difference in the combined rate of all-cause mortality, all-cause, One year|Primary end point: Major adverse events (Mortality and rehospitalization) in STEMI (-) OMI (+) subgroup, The co-primary endpoint is all-cause mortality and all-cause re-hospitalization in OMI (+) STEMI (-) patient subgroups., One year
Secondary Outcome Measures: Secondary end point: Diagnosis of acute coronary occlusion, The presence of ACO on angiogram, One week|Secondary end point: Short-term major cardiovascular events, The occurrence of in-hospital CPR, intubation and mortality., One month
Other Outcome Measures: Secondary end point: Infarct size by biomarkers, Infarct size measurement size as defined by 24-72 hour peak troponin, 72 hours|Secondary end point: Infarct size by echocardiography, Infarct size measurement size by wall motion score index (WMSI) and left ventricular ejection fraction (LVEF)., One week