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Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction

NCT06910436 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-04-21

No results posted yet for this study

Summary

The present study is practice-driven and merely observational and prospective. In clinical routine, patients who suffer from suspected ACS and do not show ST elevation in the ECG, different timing proposals in the guidelines and logistically driven differences lead to considerably variable timings in invasive coronary anatomy assessments. This handling may lead to larger infarct sizes when OMI is overseen. Therefore, the present study aims to observe a) whether an AI model is capable of correctly identify OMI in eligible patients and b) if in these patients troponin peak levels vary depending on the elapsed time between OMI diagnosis and coronary intervention.

As the model has not been established yet clinically and in the guidelines, it is safe to assume the usual pathway from first medical contact to specialist's attention is undertaken. When a patient presents in an emergency department or places an emergency call, the physicians assess the situation as usal and as stated in the current guidelines1.

If no STEMI is confirmed, the NSTE-ACS protocol is started. The patients who are ruled out for ACS are excluded from the final analysis (screening). In this case, the AI model is tested on their ECG in order to assess whether there are false positives.

The patients which are in the ACS "rule-in" trail and undergo final coronary angiography will naturally be divided in patients which were classified as OMI and as non-OMI by the AI model. Furthermore, they will present a different "Time from OMI diagnosis to PCI) and variable troponin peak levels.

By leveraging this natural variability, a practical distinction and multiple analyses can be done:

1. The feasibility of AI-powered ECG interpretation in the care of patients with suspected ACS and without clear ST-elevation infarction
2. The accuracy of AI-powered ECG interpretation in detecting OMI compared to the classical STEMI criteria
3. How infarct size correlates with different ECG readings by AI and (hypothesis generating) if changing the clinical practice could lead to a benefit in patients with suspected OMI.

Conditions

  • Coronary Arterial Disease (CAD)
  • Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Interventions

DIAGNOSTIC_TEST

Coronary Angiogram

Diagnostic/therapeutic procedure to reopen an occluded coronary artery by inflating a balloon and inserting a stent

Sponsors & Collaborators

  • Azienda Ospedaliera di Bolzano

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Italy

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 NCT06910436 on ClinicalTrials.gov