Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction

NCT07077057 | Recruiting

• 1 other identifier: 2024-01655
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does AI-assisted ECG interpretation enable more timely identification and treatment of OMI, as defined by earlier initiation of coronary intervention?
2. 2.Does AI-assisted diagnosis reduce infarct size, measured by peak high-sensitivity troponin T (hsTnT) levels?
3. 3.Present with symptoms suggestive of ACS but without clear STEMI criteria
4. 4.Be randomized 1:1 to either AI-assisted or standard ECG interpretation
5. 5.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)

Keywords

Occlusion Myocardial Infarction; Electrocardiogram; Artificial Intelligence

Outcome Measures

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.

  30 days

Secondary Outcomes (21)

• Cardiovascular mortality at 30 days

  30 days

• Timely treatment of TIMI 0-1 occlusions

  Periprocedural

• Time-to-treatment of TIMI 0-1 occlusions

  Periprocedural

• Peak hsTnT levels

  48 hours from randomization or intervention

• Major adverse cardiovascular events (MACE) at follow-up

  up to 10 years

Other Outcomes (2)

• Pre-procedural ECG analysis

  periprocedural

• Alternative OMI definitions

  30 days

Study Arms (2)

AI-assisted ECG interpretation

EXPERIMENTAL

Participants will receive ECG interpretation supported by a CE-marked artificial intelligence (AI) tool (PMcardio, Powerful Medical). The AI output is made available to clinicians in real time, prior to diagnostic or therapeutic decisions, to facilitate earlier identification of occlusion myocardial infarction (OMI) and potentially expedite intervention.

Diagnostic Test: AI-assisted ECG interpretation (PMcardio)

Standard of Care

NO INTERVENTION

Participants will receive standard ECG interpretation without AI support. Clinical decisions regarding diagnosis and treatment will follow usual care pathways, without influence from the AI tool. This arm serves as the comparator to evaluate the added value of AI integration.

Interventions

AI-assisted ECG interpretation (PMcardio) DIAGNOSTIC_TEST

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.

AI-assisted ECG interpretation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiocentro Ticino: lead

Study Sites (1)

Cardiocentro Ticino Institute

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of Cardiology

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 22, 2025
• Study Start: August 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Reasonable request

Locations

CH (1)