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Powerful Medical
•
1. October 2024
•
1 min to read
  • Multicenter Clinical Investigation

Time for a Diagnostic Paradigm Shift From STEMI/​NSTEMI to OMI/​NOMI (DIFOCCULT-3)

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Summary

DIFOCCULT-3 is a randomized controlled study actively enrolling patients across 18 sites in Turkey. It evaluates AI-assisted ECG interpretation in detecting high-risk heart attack patterns.

By comparing traditional STEMI/NSTEMI classification with an occlusion/non-occlusion (OMI/NOMI) model, the trial aims to improve acute coronary occlusion detection. The primary composite endpoint includes all-cause mortality and all-cause re-hospitalization at 1-year follow-up, assessing its impact on long-term patient outcomes.

Study DesignRandomized Controlled Trial (RCT)
StatusEnrolling patients
Countries / Sites1 (Turkey) / 18
Study StartOctober 1, 2024
Primary Completion (estimated)October 1, 2025
Enrollment (target)6,000
clinicaltrials.gov ID NCT06570759

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Powerful Medical leads one of the most important shifts in modern medicine by augmenting human-made clinical decisions with artificial intelligence. Our primary focus is on cardiovascular diseases, the world’s leading cause of death.

About PMcardio

PMcardio is a CE-certified AI that reads ECGs and offers a complex assessment of 49 cardiac conditions. Clinically validated in 15+ studies and trusted by over 100,000 clinicians, it delivers rapid, expert‑level interpretations, empowering emergency physicians, GPs, nurses, paramedics, and cardiologists to act with confidence at the point of care. Available for Individuals and Organizations.

About Powerful Medical

Established in 2017, Powerful Medical has embarked on a mission to revolutionize the diagnosis and treatment of cardiovascular diseases. We are a medical company backed by 28 world-class cardiologists and led by our expert Scientific Board with decades of experience in daily patient care, clinical research, and medical devices. The results of our research are implemented, developed, certified, and brought to market by our 50+ strong interdisciplinary team of physicians, data scientists, AI experts, software engineers, regulatory specialists, and commercial teams.

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Relevant Publications

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  • Study
  • The Journal of the American College of Cardiology
  • August 31, 2025

Hyperacute T Waves are specific for Occlusion Myocardial Infarction, even without diagnostic ST elevation

This study aimed to derive and validate a quantitative definition of hyperacute T waves (HATW) by developing the HATW score and evaluating its diagnostic accuracy for identifying acute coronary occlusion in patients with possible ACS but without STEMI criteria.
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  • Advances in Interventional Cardiology
  • May 19, 2025

Occlusion myocardial infarction: a revolution in acutecoronary syndrome

The 2025 ACC Guideline for the Management of Patients With Acute Coronary Syndromes claims that “Patients with NSTEMI may have a partially occluded coronary artery leading to subendocardial ischemia, while those with STEMI typically have a completely occluded vessel leading to transmural myocardial ischemia and infarction.” This is accompanied by a visual representation of a partially occlusive thrombus labeled ‘NSTEMI’ above an electrocardiogram (ECG) showing ST depression and T wave inversion, and a completely occlusive thrombus labeled ‘STEMI’ above an ECG showing ST elevation. This paradigm has remained despite two decades of angiographic and evidence-based ECG advances, which highlight the multiple reasons why a revolution in acute coronary syndrome (ACS) is needed, and has begun.
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PMcardio is CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. PMcardio technology has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region. Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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