Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction (TITAN-OMI)

Cardiocentro Ticino

Status: Not yet enrolling

Conditions: Myocardial Infarction (MI); Acute Coronary Syndrome (ACS)

Treatments: Diagnostic Test: AI-assisted ECG interpretation (PMcardio)

Study type: Interventional

Funder types: Other

Identifiers

NCT07077057

2024-01655

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Age: Patients aged 18 years or older.
3. Informed Consent: Patients able to provide informed consent

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

AI-assisted ECG interpretation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: AI-assisted ECG interpretation (PMcardio)

Standard of Care

No Intervention group

Description:

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.