Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction
NCT ID: NCT07077057
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
500 participants
INTERVENTIONAL
2025-08-31
2027-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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AI-assisted ECG interpretation
Participants will receive ECG interpretation supported by a CE-marked artificial intelligence (AI) tool (PMcardio, Powerful Medical). The AI output is made available to clinicians in real time, prior to diagnostic or therapeutic decisions, to facilitate earlier identification of occlusion myocardial infarction (OMI) and potentially expedite intervention.
AI-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.
Standard of Care
Participants will receive standard ECG interpretation without AI support. Clinical decisions regarding diagnosis and treatment will follow usual care pathways, without influence from the AI tool. This arm serves as the comparator to evaluate the added value of AI integration.
No interventions assigned to this group
Interventions
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AI-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.
Eligibility Criteria
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Inclusion Criteria
2. Age: Patients aged 18 years or older.
3. Informed Consent: Patients able to provide informed consent
Exclusion Criteria
2. Pregnancy or Lactation.
3. Legally incompetent to provide informed consent.
4. Symptoms onset\>24 hrs prior to clinical presentation.
18 Years
ALL
No
Sponsors
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Cardiocentro Ticino
OTHER
Responsible Party
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Marco Valgimigli
Deputy Chief of Cardiology
Locations
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Cardiocentro Ticino Institute
Lugano, Canton Ticino, Switzerland
Countries
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Facility Contacts
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Other Identifiers
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2024-01655
Identifier Type: -
Identifier Source: org_study_id
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