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

Emre K Aslanger1, Burcu Aggül2, Özlem Yıldırımtürk3

  • 1Health Sciences University, Başakşehir Pine and Sakura City Hospital, Department of Cardiology, Istanbul, Türkiye.

JACC. Advances
|October 23, 2025
PubMed

Insights

The new occlusive myocardial infarction (OMI) and nonocclusive myocardial infarction (NOMI) paradigm aims to improve acute coronary occlusion (ACO) detection over the traditional ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) approach. This study will determine if OMI/NOMI improves patient outcomes.

Area of Science:

  • Cardiology
  • Medical Diagnostics
  • Clinical Trials

Background:

  • Current ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) paradigms have limitations in identifying acute coronary occlusion (ACO).
  • Delayed diagnosis of ACO can lead to suboptimal patient outcomes.
  • A novel pathophysiology-based strategy is needed to improve ACO detection.

Purpose of the Study:

  • To evaluate the efficacy of the occlusive myocardial infarction (OMI) and nonocclusive myocardial infarction (NOMI) paradigm in improving patient outcomes.
  • To compare the OMI/NOMI approach against the traditional STEMI/NSTEMI framework for diagnosing acute coronary occlusion.
  • To assess if integrating clinical judgment, ECG subtleties, AI, biomarkers, and imaging enhances ACO detection.

Main Methods:

  • The DIFOCCULT-3 trial is a multicenter, modified cluster-randomized, open-label study involving 6,000 participants with suspected myocardial infarction (MI).
  • The OMI/NOMI approach utilizes clinical gestalt, AI-supported ECG analysis, and adjunctive diagnostics to identify ACO.
  • Primary endpoint: composite of all-cause mortality and rehospitalization at 1 year; secondary endpoints include infarct size and ejection fraction.

Main Results:

  • Enrollment and follow-up are ongoing.
  • Acute outcomes, including earlier ACO identification and infarct size, will be reported post-enrollment.
  • Late outcomes, such as mortality and rehospitalization, will be available after 1-year follow-up.

Conclusions:

  • The DIFOCCULT-3 study will determine if the OMI/NOMI paradigm offers improved outcomes compared to the STEMI/NSTEMI framework.
  • Earlier and more accurate ACO identification is hypothesized to be a key benefit of the OMI/NOMI approach.
  • This research could lead to a significant advancement in MI care and diagnostics.
Abstract

Keywords:
ST-segment elevationacute coronary syndromesmyocardial infarctionpercutaneous coronary interventionrandomized-controlled trial

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