A Diagnostic Paradigm Shift in Acute Myocardial Infarction: Rationale and Design of the DIFOCCULT-3 Trial

Aslanger, Emre; Yıldırımtürk, Özlem; Karabay, Can; Meyers, H.; Smith, Stephen; Değertekin, Muzaffer; Meyers, H.Pendell; Smith, Stephen; Kalaycı, Belma; Erdem, Ahmet; Gürsoy, Havva; Akdi, Ahmet; Özbek, Sinan; Tanık, Veysel; Akgün, Arzu; Ekici, Ertan; Söğüt, Gürbey; Efe, Tolgahan; İbiş, Ayşenur; Tunca, Çağatay; Öz, Yunus; Uygun, İbrahim; Çuvalcıoğlu, Buse; Aydın, Muhammed; Ocaklı, Ezgi; Altuner, Tuğba; Akaslan, Dursun; Esin, Murat; Özyazgan, Burcu; Aydın, İrem; Karal, Ali; Dönmez, Esra; Özcan, Sevgi; İnce, Orhan; Deniz, Muhammed; Şahin, İrfan; Coşkun, Abuzer; Karayumak, Mustafa; İbişoğlu, Ersin; Demirhan, Uğur; Erdoğan, Aslan; Özkan, Eyüp; Çetin, İlyas; İnci, Yusuf; Kalkan, Semih; Yıldız, Ufuk; Kural, Said; Danacı, Tuba; Kırbıyık, Burcu; Işık, Merve; Uluköksal, Utku; Yücedağ, Furkan; Özoğuz, Elif; Şeker, Oktay; Yaylak, Barış; Ceylan, Ufuk; Zeren, Gönül; Sungur, Mustafa; Yılmaz, Mehmet; Onuk, Tolga; Birdal, Oğuzhan; AYDIN, Sidar; Tekin, Erdal; Varınca, Emrah; Babayiğit, Ezgi; Yalvaç, Halit; Şener, Emre; Tıraş, Hazal; Özden, Barış; Beral, Ayberk; Mert, Kadir; Mert, Gurbet; Çalışkan, Cihat; Kaya, Azmican; Kibar, Metehan; Kılıçarslan, Mustafa; Kipritçi, Emre; Atıcı, Şeyma; Erdal, Simay; Kalkan, Sedat; Geçmen, Çetin; Kahyaoğlu, Muzaffer; Aytürk, Mehmet; Demir, Mevlut; Şen, Taner; Durmuş, Halil; Kaya, Emrah; Kahraman, Fatih; Kilit, Celal; Astarcıoğlu, Mehmet; Elitas, Veysel; Yılmaz, Yakup; Güven, Uğur; Dogan, Zekeriya; Uysaler, Eren; Nizam, Ahmet; Çelik, Tansu; Türkmen, Ebrunur; Çavuş, Berke; Sünbül, Fevzi; Nasif, Sena; Gözünke, Melih; Şahin, Ahmet; Kol, Ayhan; Çeneli, Doğancan; Karacabey, Sinan; Bulut, Serhat; İnan, Ayşe; Aytemiz, Mustafa; Kudu, Emre; Korgan, Mehmet; Altun, Mustafa; Narlı, Mehmet; Yurtman, Elif; Ertürk, Mehmet; Bulut, Ümit; Kübra, Dama; Yartaşı, Utku; Huseynova, Shabnam; Coşkun, Gizemnur; Gündoğdu, Mustafa; Pay, Dilara; Başaran, Özcan; Özlek, Bülent; Altun, İbrahim; Barutçu, Süleyman; Tok, Zahit; Terdöken, Tolga; Kesriklioglu, Serhat; Kaleli, Muhammed; Düzenli, Mehmet; Toprak, Sümeyye; Recepoğlu, Ferit; Feyzullayeva, Leyla; Gezer, Mertcan; Feyzullahoglu, Emirhan; Moloshova, Nuraiym; Gür, Şener; Şalvarcı, Ahmet; Kılavuz, Mücahit; Çelik, Mustafa; Alsancak, Yakup; Gurbuz, Ahmet; Tatar, Sefa; Güven, Barış; Gökçe, Mehmet; Zorlu, Çağrı; Ömür, Sefa; Şimşek, Ahmet; Demirezen, Yağmur; Kümet, Ömer; Ayhan, Görkem; Karaduman, Medeni; Günsoy, Ertuğ; Can, Veysi; Sarıkaya, Remzi; Ceylan, Yemlihan; Kaya, Yüksel; Türkan, Mehmet; Aslanger, Emre; Aggül, Burcu; Aggül, Burcu; Yıldırımtürk, Özlem; Karabay, Can; Değertekin, Muzaffer; Acar, Gamze; Acaroğlu, Şeyma; Akgün, Hüseyin; Canbolat, Orkun; Ekici, Fatma; Göksu, Muhammed; Halil, Ufuk; Hamkan, Emel; Karaca, Furkan; Kılıç, Şevval; Özdoğan, Cansu; Saarıkafa, Furkan; Topçu, Melek; Türkmen, Ömer; Bozbeyoğlu, Emrah; Pamuk, Funda; Çanakçı, Mustafa; Güven, Ramazan

doi:10.1016/j.jacadv.2025.102227

A Diagnostic Paradigm Shift in Acute Myocardial Infarction: Rationale and Design of the DIFOCCULT-3 Trial

Aslanger E. K., Yıldırımtürk Ö., Karabay C. Y., Meyers H. P., Smith S. W., Değertekin M., ...Daha Fazla

JACC: Advances, cilt.4, sa.11, 2025 (ESCI, Scopus)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 4 Sayı: 11
Basım Tarihi: 2025
Doi Numarası: 10.1016/j.jacadv.2025.102227
Dergi Adı: JACC: Advances
Derginin Tarandığı İndeksler: Emerging Sources Citation Index (ESCI), Scopus
Anahtar Kelimeler: acute coronary syndromes, myocardial infarction, percutaneous coronary intervention, randomized-controlled trial, ST-segment elevation
Atatürk Üniversitesi Adresli: Evet

Özet

Background: The current ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) paradigm have long been the cornerstone of myocardial infarction (MI) care but fail to identify many patients with acute coronary occlusion (ACO), delaying treatment and worsening outcomes. Objectives: The new occlusive MI (OMI) and nonocclusive MI (NOMI) paradigm addresses these limitations by shifting from rigid electrocardiography (ECG)-driven thresholds to a pathophysiology-based strategy. It integrates clinical judgment, ECG subtleties, supportive artificial intelligence, biomarkers, and imaging when needed to actively detect ACO. The current trial investigates whether this approach improves outcomes. Methods: The DIFOCCULT-3 (Time for a DIagnostic paradigm shift from ST-elevation/non-ST-elevation to OCClUsion/non-occLusion myocardial infarcTion? trial is a multicenter, modified cluster-randomized, open-label study designed to compare the OMI/NOMI paradigm with the STEMI/NSTEMI approach in 6,000 participants presenting with suspected MI. The OMI/NOMI approach integrates clinical gestalt, artificial intelligence–supported ECG analysis, and adjunctive diagnostic tools to actively identify ACO. The primary endpoint is the composite of all-cause mortality and all-cause rehospitalization at 1-year follow-up. Secondary endpoints include infarct size, left ventricular ejection fraction, wall motion score index, and accurate diagnosis of ACO. Results: Enrollment and follow-up are ongoing; acute outcomes such as earlier identification of ACO and infarct size will be reported after enrollment, and late outcomes including mortality and rehospitalization will be available after 1-year follow-up. Conclusions: The DIFOCCULT-3 study aims to determine whether the OMI/NOMI paradigm represents a significant advancement in MI care by improving outcomes through earlier and more accurate identification of ACO than the STEMI/NSTEMI framework (Time for a Diagnostic Paradigm Shift From STEMI/NSTEMI to OMI/NOMI [DIFOCCULT-3]; NCT06570759)