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Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction

NCT07077057 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-05

No results posted yet for this study

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

Conditions

  • Myocardial Infarction (MI)
  • Acute Coronary Syndrome (ACS)

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 to standard ECG interpretation to support timely diagnosis and management decisions.

Sponsors & Collaborators

  • Cardiocentro Ticino

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-23
Primary Completion
2027-08-31
Completion
2027-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077057 on ClinicalTrials.gov