Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction

Not Applicable

Not yet recruiting

• Conditions: Myocardial Infarction (MI); Acute Coronary Syndrome (ACS)

• Registration Number: NCT07077057
• Lead Sponsor: Cardiocentro Ticino

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. 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-08-01
• Primary Completion: 2027-08
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. 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
2. Age: Patients aged 18 years or older.
3. Informed Consent: Patients able to provide informed consent

Exclusion Criteria

1. Clear diagnosis of ST-segment elevation MI (STEMI) according to managing physicians.
2. Pregnancy or Lactation.
3. Legally incompetent to provide informed consent.
4. Symptoms onset>24 hrs prior to clinical presentation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hierarchical primary endpoint	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality at 30 days	30 days	Cardiovascular mortality at 30 days
Timely treatment of TIMI 0-1 occlusions	Periprocedural	Timely treatment is defined as arterial sheath insertion within 120 minutes of randomization
Time-to-treatment of TIMI 0-1 occlusions	Periprocedural	Expressed in minutes from time of randomization
Peak hsTnT levels	48 hours from randomization or intervention	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.
Major adverse cardiovascular events (MACE) at follow-up	up to 10 years	Major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, or stroke at follow up (30-days, 1 year, 3/5/10 years)
Cardiovascular death at follow-up	up to 10 years	Cardiovascular death at follow up (30-days, 1 year, 3/5/10 years)
Myocardial infarction at follow-up	up to 10 years	Myocardial infarction at follow up (30-days, 1 year, 3/5/10 years)
Stroke at follow-up	up to 10 years	Stroke at follow up (30-days, 1 year, 3/5/10 years)
Infarct Size	48 hours from randomization or intervention	• CK-MB area under the curve
Time from randomization to antithrombotic therapy	periprocedural	Time from randomization to antithrombotic therapy (expressed in minutes)
Time from randomization to coronary angiography	periprocedural	Time from randomization to coronary angiography (expressed in minutes) This outcome will be assessed both in all patients and in patients with OMI according to the different definitions.
Angiographic outcomes (restricted to patients undergoing PCI)	Periprocedural	* Worst TIMI flow grade post-PCI (0-3); * Worst TIMI thrombus grade post-PCI (0-5)
Total time spent in the emergency department post-randomization	periprocedural	Total time spent in the emergency department post-randomization
Length of hospital stay post-randomization	up to 30 days	Length of hospital stay post-randomization (days)
Resource utilization	periprocedural	Number of diagnostic tests and procedures performed post-randomization before coronary angiography, including troponin measurements, transthoracic echocardiography and stress testing
Health economic outcomes	30 days	These include both direct and indirect costs.; Direct costs are defined as medical costs incurred post-randomization during the index hospitalization or emergency department visit, including diagnostics and procedures (e.g., ECG, troponin testing, coronary angiography, PCI), medications and consumables, staff time, and length of stay.; Indirect costs, defined as non-medical or societal costs up to 30 days post-randomization, including lost productivity (e.g., time off work for patients or caregivers), transportation to follow-up visits, informal caregiving support, and early rehabilitation services
Safety (Serious adverse events)	up to 10 years
Diagnostic accuracy of AI algorithm	periprocedural	Restricted to patients in the control group: * Sensitivity; * Specificity; * Positive predictive value (PPV); * Negative predictive value (NPV)
Quality of life (EQ-5D-5L)	up to 30 days	Health-related quality of life, assessed using the EQ-5D-5L instrument at discharge and 30 days post-randomization

Trial Locations

Locations (1)

Cardiocentro Ticino Institute; 🇨🇭 Lugano, Ticino, Switzerland