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Powerful Medical
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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
  • European Heart Journal – Digital Health
  • December 2, 2025

An AI Model for Electrocardiogram Detection of Occlusion Myocardial Infarction: A Retrospective Study to Reduce False Positive Cath Lab Activations

This single-centre retrospective study examined whether an AI-powered ECG model (PMcardio’s Queen of Hearts OMI model) can better detect acute occlusion myocardial infarction (OMI) and reduce false-positive cardiac catheterization laboratory (CCL) activations compared with traditional STEMI millimetre criteria. The authors analysed 304 consecutive STEMI pathway activations over a 2-year period at a tertiary academic centre and applied the AI model to pre-angiography 12-lead ECGs, comparing its performance against standard STEMI criteria. The AI model showed higher sensitivity (89.2% vs 68.3%), higher specificity (72.9% vs 51.7%), greater overall accuracy (82.9% vs 61.8%), and a high AUROC of 0.884 for identifying true OMI, while correctly flagging nearly three-quarters of false-positive activations as non-OMI. These findings suggest that integrating a specialized AI-ECG model into existing STEMI alert pathways could meaningfully reduce unnecessary CCL activations without compromising the detection of true occlusions.
  • Case Report
  • Cureus
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Bifascicular Block Associated With Myocardial Infarction: A Marker of Proximal Left Anterior Descending Artery Occlusion Confirmed by the Artificial Intelligence-Based Smartphone App Queen of Hearts

This single-patient case report describes an elderly man presenting with chest pain, hypotension, and bifascicular block (BFB)—a combination of right bundle branch block (RBBB) and left anterior fascicular block (LAFB)—whose ECG showed QRS‑concordant anterior and lateral ST‑segment elevation consistent with a STEMI‑equivalent / occlusive myocardial infarction (OMI) pattern. Urgent coronary angiography revealed a long, severely calcified, near‑occlusive proximal left anterior descending (LAD) artery lesion, successfully treated with primary PCI and drug‑eluting stent implantation, achieving TIMI 3 flow. The Queen of Hearts (PMcardio) AI‑based smartphone app correctly classified the ECG as STEMI‑equivalent, identified atrial flutter and BFB, and predicted reduced left ventricular ejection fraction, later confirmed by echocardiography (EF 38%). This case underscores BFB with concordant anterior ST elevation as a high‑risk marker of proximal LAD‑culprit OMI and provides anecdotal evidence that specialized AI‑enabled ECG interpretation can support rapid, accurate decision‑making in ACS. 
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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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