Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-assisted ECG interpretation (PMcardio).
- Who it may be relevant to
- Registry conditions: Myocardial Infarction (MI), Acute Coronary Syndrome (ACS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Diagnostic test 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
Primary outcome measures
- Hierarchical primary endpoint [Time frame: 30 days]
Secondary outcome measures (12)
- Cardiovascular mortality at 30 days [Time frame: 30 days]
- Timely treatment of TIMI 0-1 occlusions [Time frame: Periprocedural]
- Time-to-treatment of TIMI 0-1 occlusions [Time frame: Periprocedural]
- Peak hsTnT levels [Time frame: 48 hours from randomization or intervention]
- Major adverse cardiovascular events (MACE) at follow-up [Time frame: up to 10 years]
- Cardiovascular death at follow-up [Time frame: up to 10 years]
- Myocardial infarction at follow-up [Time frame: up to 10 years]
- Stroke at follow-up [Time frame: up to 10 years]
- Infarct Size [Time frame: 48 hours from randomization or intervention]
- Infarct Size [Time frame: 48 hours from randomization or intervention]
- Infarct Size [Time frame: 48 hours from randomization or intervention]
- Time from randomization to antithrombotic therapy [Time frame: periprocedural]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Switzerland · 1 center
- Cardiocentro Ticino Institute — Lugano
Identifiers
NCT: NCT07077057 · 2024-01655