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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:
Researchers will compare AI-assisted ECG interpretation to standard care to determine if the AI tool improves clinical outcomes and care timelines.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hierarchical primary endpoint | The primary endpoint of the prospective phase, analysed hierarchically using the unmatched, unstratified win ratio, will be a composite of:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular mortality at 30 days | Cardiovascular mortality at 30 days | 30 days |
| Timely treatment of TIMI 0-1 occlusions | Timely treatment is defined as arterial sheath insertion within 120 minutes of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-procedural ECG analysis | Sensitivity analysis of diagnostic accuracy of the AI-algorithm based on the 12-lead ECG recorded immediately prior to the start of coronary angiography, instead of the ECG at presentation. | periprocedural |
| Alternative OMI definitions |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiocentro Ticino Institute | Recruiting | Lugano | Canton Ticino | 6900 | Switzerland |
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Reasonable request
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Periprocedural |
| Time-to-treatment of TIMI 0-1 occlusions | Expressed in minutes from time of randomization | 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. | 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) | up to 10 years |
| Cardiovascular death at follow-up | Cardiovascular death at follow up (30-days, 1 year, 3/5/10 years) | up to 10 years |
| Myocardial infarction at follow-up | Myocardial infarction at follow up (30-days, 1 year, 3/5/10 years) | up to 10 years |
| Stroke at follow-up | Stroke at follow up (30-days, 1 year, 3/5/10 years) | up to 10 years |
| Infarct Size | • hsTnT area under the curve | 48 hours from randomization or intervention |
| Infarct Size | • Creatine kinase-MB (CK-MB) peak concentration | 48 hours from randomization or intervention |
| Infarct Size | • CK-MB area under the curve | 48 hours from randomization or intervention |
| Time from randomization to antithrombotic therapy | Time from randomization to antithrombotic therapy (expressed in minutes) | 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. | periprocedural |
| Angiographic outcomes (restricted to patients undergoing PCI) |
| Periprocedural |
| Total time spent in the emergency department post-randomization | Total time spent in the emergency department post-randomization | periprocedural |
| Length of hospital stay post-randomization | Length of hospital stay post-randomization (days) | 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 | 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 | 30 days |
| Safety (Serious adverse events) | up to 10 years |
| Diagnostic accuracy of AI algorithm | Restricted to patients in the control group:
| 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. | up to 30 days |
Sensitivity analysis of the primary outcome using an alternative definition of OMI: TIMI flow 0-1, or TIMI flow 2-3 in the presence of large thrombus burden (TIMI thrombus grade ≥3). |
| 30 days |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |