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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
500
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.
Cardiocentro Ticino Institute
Lugano, Canton Ticino, Switzerland
RECRUITINGHierarchical 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.
Time frame: 30 days
Cardiovascular mortality at 30 days
Cardiovascular mortality at 30 days
Time frame: 30 days
Timely treatment of TIMI 0-1 occlusions
Timely treatment is defined as arterial sheath insertion within 120 minutes of randomization
Time frame: Periprocedural
Time-to-treatment of TIMI 0-1 occlusions
Expressed in minutes from time of randomization
Time frame: Periprocedural
Peak hsTnT levels
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.
Time frame: 48 hours from randomization or intervention
Major adverse cardiovascular events (MACE) at follow-up
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)
Time frame: up to 10 years
Cardiovascular death at follow-up
Cardiovascular death at follow up (30-days, 1 year, 3/5/10 years)
Time frame: up to 10 years
Myocardial infarction at follow-up
Myocardial infarction at follow up (30-days, 1 year, 3/5/10 years)
Time frame: up to 10 years
Stroke at follow-up
Stroke at follow up (30-days, 1 year, 3/5/10 years)
Time frame: up to 10 years
Infarct Size
• hsTnT area under the curve
Time frame: 48 hours from randomization or intervention
Infarct Size
• Creatine kinase-MB (CK-MB) peak concentration
Time frame: 48 hours from randomization or intervention
Infarct Size
• CK-MB area under the curve
Time frame: 48 hours from randomization or intervention
Time from randomization to antithrombotic therapy
Time from randomization to antithrombotic therapy (expressed in minutes)
Time frame: periprocedural
Time from randomization to coronary angiography
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.
Time frame: periprocedural
Angiographic outcomes (restricted to patients undergoing PCI)
* Worst TIMI flow grade post-PCI (0-3) * Worst TIMI thrombus grade post-PCI (0-5)
Time frame: Periprocedural
Total time spent in the emergency department post-randomization
Total time spent in the emergency department post-randomization
Time frame: periprocedural
Length of hospital stay post-randomization
Length of hospital stay post-randomization (days)
Time frame: up to 30 days
Resource utilization
Number of diagnostic tests and procedures performed post-randomization before coronary angiography, including troponin measurements, transthoracic echocardiography and stress testing
Time frame: periprocedural
Health economic outcomes
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
Time frame: 30 days
Safety (Serious adverse events)
Time frame: up to 10 years
Diagnostic accuracy of AI algorithm
Restricted to patients in the control group: * Sensitivity * Specificity * Positive predictive value (PPV) * Negative predictive value (NPV)
Time frame: periprocedural
Quality of life (EuroQol 5-Dimension 5-Level [EQ-5D-5L] Index Score)
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument at discharge and 30 days post-randomization. The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses are converted into a single index score using a country-specific value set. The index score typically ranges from values below 0 (worse than death) to 1 (full health), with higher scores indicating better health-related quality of life.
Time frame: up to 30 days
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