Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiocentro Ticino
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
AI-assisted ECG interpretation (PMcardio)
Diagnostic testParticipants 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: AI-assisted ECG interpretationExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Hierarchical primary endpoint
The primary endpoint of the prospective phase, analysed hierarchically using the unmatched, unstratified win ratio, will be a composite of: * Cardiovascular mortality at 30 days. * Timely treatment of angiographically confirmed TIMI 0-1 occlusions, defined as insertion of the arterial sheath within 120 minutes from randomization. * Time-to-treatment of angiographically confirmed TIMI 0-1 occlusions. * Peak high- hsTnT levels in ng/mL as a surrogate measure of infarct size. Time of coronary intervention will be defined as time from randomisation to insertion of the arterial sheath. Peak hsTnT is defined as the maximum level of hsTnT within 48h from randomization or within 48 hours from intervention if percutaneous coronary intervention took place later than 24 hours from randomization.
Time frame
30 daysSecondary outcomes
1
Cardiovascular mortality at 30 days
Cardiovascular mortality at 30 days
Time frame
30 days2
Timely treatment of TIMI 0-1 occlusions
Timely treatment is defined as arterial sheath insertion within 120 minutes of randomization
Time frame
Periprocedural3
Time-to-treatment of TIMI 0-1 occlusions
Expressed in minutes from time of randomization
Time frame
Periprocedural4
Peak hsTnT levels
Peak hsTnT is defined as the maximum level of hsTnT within 48h from randomization or within 48 hours from intervention if percutaneous coronary intervention took place later than 24 hours from randomization.
Time frame
48 hours from randomization or interventionOther outcomes
1
Pre-procedural ECG analysis
Sensitivity analysis of diagnostic accuracy of the AI-algorithm based on the 12-lead ECG recorded immediately prior to the start of coronary angiography, instead of the ECG at presentation.
Time frame
periprocedural2
Alternative OMI definitions
Sensitivity analysis of the primary outcome using an alternative definition of OMI: TIMI flow 0-1, or TIMI flow 2-3 in the presence of large thrombus burden (TIMI thrombus grade ≥3).
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov