RecruitingNot ApplicableNCT07077057

Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction

Sponsor

Cardiocentro Ticino

Enrollment

500 participants

Start Date

Aug 23, 2025

Study Type

INTERVENTIONAL

Conditions

Myocardial Infarction (MI)Acute Coronary Syndrome (ACS)

Summary

The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based ECG interpretation tool improves the early diagnosis and treatment of occlusion myocardial infarction (OMI) in adults presenting with suspected acute coronary syndrome (ACS) who do not meet traditional ST-elevation myocardial infarction (STEMI) criteria. The main questions it aims to answer are: 1. Does AI-assisted ECG interpretation enable more timely identification and treatment of OMI, as defined by earlier initiation of coronary intervention? 2. Does AI-assisted diagnosis reduce infarct size, measured by peak high-sensitivity troponin T (hsTnT) levels? Researchers will compare AI-assisted ECG interpretation to standard care to determine if the AI tool improves clinical outcomes and care timelines. Participants will: 1. Present with symptoms suggestive of ACS but without clear STEMI criteria 2. Be randomized 1:1 to either AI-assisted or standard ECG interpretation 3. Undergo follow-up assessments for cardiovascular outcomes, including 30-day death, time to treatment of total coronary occlusion, and peak hsTnT levels

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Symptoms suspected of ongoing acute myocardial ischemia: Patients presenting with symptoms such as chest pain, dyspnoea, sweating, nausea or vomiting, pain radiating to the shoulder/arm/jaw/back, fatigue, or light-headedness
Age: Patients aged 18 years or older.
Informed Consent: Patients able to provide informed consent

Exclusion Criteria4

Clear diagnosis of ST-segment elevation MI (STEMI) according to managing physicians.
Pregnancy or Lactation.
Legally incompetent to provide informed consent.
Symptoms onset>24 hrs prior to clinical presentation.

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Interventions

DIAGNOSTIC_TESTAI-assisted ECG interpretation (PMcardio)

Participants in the experimental arm will undergo 12-lead ECG interpretation supported by a CE-marked artificial intelligence (AI) tool (PMcardio, Powerful Medical, Slovakia). The AI algorithm analyzes ECG data in real time to detect patterns suggestive of occlusion myocardial infarction (OMI), including cases not meeting traditional ST-elevation myocardial infarction (STEMI) criteria. In the experimental arm, the AI output is provided immediately to the treating clinician and used as an adjunct to standard ECG interpretation to support timely diagnosis and management decisions.