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AID-OMIE - Artificial Intelligence in Detection of Occlusive Myocardial Infarction in Emergency Medicine

I

Institute of Mountain Emergency Medicine

Status

Not yet enrolling

Conditions

Cardiac Arrest, Out-Of-Hospital
Cardiac Arrest Due to Underlying Cardiac Condition

Study type

Observational

Funder types

Other

Identifiers

NCT06767709
01-2025

Details and patient eligibility

About

Study Objective and Hypothesis The study hypothesizes that artificial intelligence (AI)-assisted interpretation of the 12-lead electrocardiogram (ECG) can improve the care of patients resuscitated after out-of-hospital cardiac arrest (OHCA) by enabling faster and more accurate detection of occlusion myocardial infarction (OMI). This enhanced diagnostic approach could reduce the time required for revascularization, improve patient outcomes, and decrease unnecessary activations of cardiac catheterization laboratories. The primary objective of the study is to assess the effectiveness of an AI-powered ECG model in identifying acute OMI in OHCA patients whose post-return of spontaneous circulation (ROSC) ECG does not show ST-elevation.

Methods

This is a retrospective observational study involving OHCA patients in Bolzano, Italy, who meet the following inclusion criteria:

Aged 18 years or older. Achieved ROSC after cardiac arrest. Underwent coronary angiography (CAG) within seven days post-OHCA. Prehospital post-ROSC ECG and CAG reports available.

Exclusion criteria include in-hospital cardiac arrest (IHCA), traumatic cardiac arrest, cardiac arrest from a non-cardiac cause, and poor-quality or corrupted ECG images. Post-ROSC ECGs will be analyzed using the PMcardio App, an AI tool for ECG interpretation. The data will be fully anonymized before storage. Coronary angiography charts will be reviewed for the presence of atherosclerotic lesions, the degree of arterial narrowing, and Thrombolysis in Myocardial Infarction (TIMI) flow, which assesses blood flow in coronary arteries.

Study Outcomes The primary outcome is the sensitivity and specificity of the AI-assisted ECG in detecting OMI in patients whose post-ROSC ECG does not show ST-elevation. Secondary outcomes include the frequency of OMI in OHCA patients without ST-elevation and the ability of the AI model to rule out OMI accurately in these cases.

Full description

Study Objective and Hypothesis The study hypothesizes that artificial intelligence (AI)-assisted interpretation of the 12-lead electrocardiogram (ECG) can improve the care of patients resuscitated after out-of-hospital cardiac arrest (OHCA) by enabling faster and more accurate detection of occlusion myocardial infarction (OMI). This enhanced diagnostic approach could reduce the time required for revascularization, improve patient outcomes, and decrease unnecessary activations of cardiac catheterization laboratories. The primary objective of the study is to assess the effectiveness of an AI-powered ECG model in identifying acute OMI in OHCA patients whose post-return of spontaneous circulation (ROSC) ECG does not show ST-elevation.

Methods

This is a retrospective observational study involving OHCA patients in Bolzano, Italy, who meet the following inclusion criteria:

OHCA from 2018-2025 Aged 18 years or older. Achieved ROSC after cardiac arrest. Underwent coronary angiography (CAG) within seven days post-OHCA. Prehospital post-ROSC ECG and CAG reports available.

Exclusion criteria include in-hospital cardiac arrest (IHCA), traumatic cardiac arrest, cardiac arrest from a non-cardiac cause, and poor-quality or corrupted ECG images. Post-ROSC ECGs will be analyzed using the PMcardio App, an AI tool for ECG interpretation. The data will be fully anonymized before storage. Coronary angiography charts will be reviewed for the presence of atherosclerotic lesions, the degree of arterial narrowing, and Thrombolysis in Myocardial Infarction (TIMI) flow, which assesses blood flow in coronary arteries.

Study Outcomes The primary outcome is the sensitivity and specificity of the AI-assisted ECG in detecting OMI in patients whose post-ROSC ECG does not show ST-elevation. Secondary outcomes include the frequency of OMI in OHCA patients without ST-elevation and the ability of the AI model to rule out OMI accurately in these cases.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • OHCA from with ROSC in the Province of Bolzano, Italy
  • Coronary angiography (CAG) within 7 days post-OHCA
  • Age > 18 years
  • Available prehospital post-ROSC ECG
  • Available CAG report

Exclusion criteria

  • In-Hospital Cardiac Arrest (IHCA)
  • Age < 18 years
  • Traumatic cardiac arrest
  • Cardiac arrest from a clear non-cardiac cause
  • Corrupted ECG images
  • Poor ECG digitalization quality

Trial design

200 participants in 1 patient group

Patients after Out-of-Hospital Cardiac Arrest (OHCA) with ROSC in the Province of Bolzano, Italy
Description:
Patients after Out-of-Hospital Cardiac Arrest (OHCA) with Return of Spontaneous Circulation (ROSC) in the Province of Bolzano, Italy

Trial contacts and locations

0

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Central trial contact

Simon Rauch, MD, PhD

Data sourced from clinicaltrials.gov

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