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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 23 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 model, the trial aims to improve acute coronary blockage 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) / 23
Study StartOctober 1, 2024
Primary Completion (estimated)October 1, 2025
Enrollment (target)5,000
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 the market leader in AI-powered diagnostics, addressing the world’s leading cause of death – cardiovascular diseases. The innovative clinical assistant empowers healthcare professionals to detect up to 40 cardiovascular diseases. In the form of a smartphone application, the certified Class IIb medical device interprets any 12-lead ECG image in under 5 seconds to provide accurate diagnoses and individualized treatment recommendations tailored to each patient.

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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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.

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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