Not yet recruiting NCT06767709

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Cardiac Arrest, Out-Of-Hospital, Cardiac Arrest Due to Underlying Cardiac Condition. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Primary outcome measures

Sensitivity and specificity of detecting OMI from the post-ROSC ECG with AI-assisted ECG interpretation in patients following OHCA with ROSC, where the post-ROSC ECG does not show ST-elevation. [Time frame: Within 7 days after OHCA]

Secondary outcome measures (2)

Frequency of OMI post-OHCA without ST-elevation in the post-ROSC ECG [Time frame: Within 7 days after OHCA]
Sensitivity and specificity of excluding OMI with AI-assisted ECG interpretation in patients following OHCA with ROSC, where the post-ROSC ECG does not show ST-elevation. [Time frame: Within 7 days from OHCA]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06767709 · 01-2025

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗