A Diagnostic Paradigm Shift in Acute Myocardial Infarction: Rationale and Design of the DIFOCCULT-3 Trial
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)
Anahtar kelimeler
Atıf için künye
Aslanger, E. K., Yıldırımtürk, Ö., Karabay, C. Y., Meyers, H. P., Smith, S. W., Değertekin, M., Meyers, H., Smith, S. W., Kalaycı, B., Erdem, A. B., Gürsoy, H. T., Akdi, A., Özbek, S. C., Tanık, V. O., Akgün, A. N., Ekici, E., Söğüt, G., Efe, T., İbiş, A. Ö., … Güven, R. (2025). A Diagnostic Paradigm Shift in Acute Myocardial Infarction: Rationale and Design of the DIFOCCULT-3 Trial. JACC: Advances, 4(11). https://doi.org/10.1016/j.jacadv.2025.102227
BibTeX
@article{aslanger2025-220510,
author = {Aslanger, Emre K. and Yıldırımtürk, Özlem and Karabay, Can Yücel and Meyers, H. Pendell and Smith, Stephen W. and Değertekin, Muzaffer and Meyers, H.Pendell and Smith, Stephen W. and Kalaycı, Belma and Erdem, Ahmet Burak and Gürsoy, Havva Tuğba and Akdi, Ahmet and Özbek, Sinan Cemgil and Tanık, Veysel Ozan and Akgün, Arzu Neslihan and Ekici, Ertan and Söğüt, Gürbey and Efe, Tolgahan and İbiş, Ayşenur Özkaya and Tunca, Çağatay and Öz, Yunus and Uygun, İbrahim Halil and Çuvalcıoğlu, Buse and Aydın, Muhammed and Ocaklı, Ezgi Polat and Altuner, Tuğba Kayhan and Akaslan, Dursun and Esin, Murat and Özyazgan, Burcu and Aydın, İrem Kılınçkaya and Karal, Ali Oğuzhan and Dönmez, Esra and Özcan, Sevgi and İnce, Orhan and Deniz, Muhammed Furkan and Şahin, İrfan and Coşkun, Abuzer and Karayumak, Mustafa Rauf and İbişoğlu, Ersin and Demirhan, Uğur Ozan and Erdoğan, Aslan and Özkan, Eyüp and Çetin, İlyas and İnci, Yusuf and Kalkan, Semih and Yıldız, Ufuk and Kural, Said and Danacı, Tuba and Kırbıyık, Burcu and Işık, Merve Aslı and Uluköksal, Utku and Yücedağ, Furkan Fatih and Özoğuz, Elif and Şeker, Oktay and Yaylak, Barış and Ceylan, Ufuk Sadık and Zeren, Gönül and Sungur, Mustafa Azmi and Yılmaz, Mehmet Fatih and Onuk, Tolga and Birdal, Oğuzhan and AYDIN, Sidar Şiyar and Tekin, Erdal and Varınca, Emrah İlkay and Babayiğit, Ezgi Çamlı and Yalvaç, Halit Emre and Şener, Emre and Tıraş, Hazal and Özden, Barış and Beral, Ayberk and Mert, Kadir Uğur and Mert, Gurbet Özge and Çalışkan, Cihat and Kaya, Azmican and Kibar, Metehan and Kılıçarslan, Mustafa Furkan and Kipritçi, Emre and Atıcı, Şeyma Zeynep and Erdal, Simay and Kalkan, Sedat and Geçmen, Çetin and Kahyaoğlu, Muzaffer and Aytürk, Mehmet and Demir, Mevlut and Şen, Taner and Durmuş, Halil İbrahim and Kaya, Emrah and Kahraman, Fatih and Kilit, Celal and Astarcıoğlu, Mehmet Ali and Elitas, Veysel and Yılmaz, Yakup Han and Güven, Uğur and Dogan, Zekeriya and Uysaler, Eren and Nizam, Ahmet Cem and Çelik, Tansu and Türkmen, Ebrunur and Çavuş, Berke and Sünbül, Fevzi and Nasif, Sena and Gözünke, Melih and Şahin, Ahmet Anıl and Kol, Ayhan and Çeneli, Doğancan and Karacabey, Sinan and Bulut, Serhat and İnan, Ayşe Zeynep and Aytemiz, Mustafa and Kudu, Emre and Korgan, Mehmet Birkan and Altun, Mustafa and Narlı, Mehmet Oğuzhan and Yurtman, Elif Yaren and Ertürk, Mehmet and Bulut, Ümit and Kübra, Dama Hatice and Yartaşı, Utku and Huseynova, Shabnam and Coşkun, Gizemnur and Gündoğdu, Mustafa Can and Pay, Dilara and Başaran, Özcan and Özlek, Bülent and Altun, İbrahim and Barutçu, Süleyman and Tok, Zahit Arda and Terdöken, Tolga and Kesriklioglu, Serhat and Kaleli, Muhammed Fatih and Düzenli, Mehmet Akif and Toprak, Sümeyye and Recepoğlu, Ferit and Feyzullayeva, Leyla and Gezer, Mertcan and Feyzullahoglu, Emirhan and Moloshova, Nuraiym and Gür, Şener and Şalvarcı, Ahmet and Kılavuz, Mücahit and Çelik, Mustafa and Alsancak, Yakup and Gurbuz, Ahmet Seyfeddin and Tatar, Sefa and Güven, Barış and Gökçe, Mehmet Emin and Zorlu, Çağrı and Ömür, Sefa Erdi and Şimşek, Ahmet and Demirezen, Yağmur and Kümet, Ömer and Ayhan, Görkem and Karaduman, Medeni and Günsoy, Ertuğ and Can, Veysi and Sarıkaya, Remzi and Ceylan, Yemlihan and Kaya, Yüksel and Türkan, Mehmet Şirin and Aslanger, Emre K. and Aggül, Burcu and Aggül, Burcu and Yıldırımtürk, Özlem and Karabay, Can Yücel and Değertekin, Muzaffer and Acar, Gamze and Acaroğlu, Şeyma and Akgün, Hüseyin and Canbolat, Orkun and Ekici, Fatma and Göksu, Muhammed Mert and Halil, Ufuk Sali and Hamkan, Emel and Karaca, Furkan and Kılıç, Şevval and Özdoğan, Cansu Göksenin and Saarıkafa, Furkan and Topçu, Melek and Türkmen, Ömer and Bozbeyoğlu, Emrah and Pamuk, Funda Özlem and Çanakçı, Mustafa Emin and Güven, Ramazan},
title = {A Diagnostic Paradigm Shift in Acute Myocardial Infarction: Rationale and Design of the DIFOCCULT-3 Trial},
journal = {JACC: Advances},
year = {2025},
volume = {4},
number = {11},
issn = {2772-963X},
doi = {10.1016/j.jacadv.2025.102227},
url = {https://akademik.atauni.edu.tr/yayinlar/220510-a-diagnostic-paradigm-shift-in-acute-myocardial-infarction-rationale-and-design}
}