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AI ECG TIMI is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an AI model predicting coronary blood flow alteration. The aim of the study is to identify electrocardiographic findings detected by an automated artificial intelligence (AI) model that can predict coronary blood flow alteration as assessed by the TIMI grade flow at the very moment of the invasive coronary angiography in patients with acute coronary syndromes.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of the AI-ECG TIMI AI Model | The primary endpoint is the AI-ECG TIMI model's ability to identify patients with actively occluded (TIMI 0-1) at the time of invasive coronary angiography using only single-standard 12-lead ECGs assessed by accuracy, sensitivity, specificity, positive, negative predictive values and F1 scores. | Index hospitalization (assessed up to 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup Performance | AI-ECG TIMI AI Model's performance across subgroups
| Index hospitalization (assessed up to 5 days) |
| Correlate established definitions of occlusion myocardial infarction (OMI) to myocardial perfusion status |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (18 or older) with acute coronary syndrome undergoing clinically indicated invasive coronary angiography, with a standard 12-lead ECG performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access)
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| Name | Affiliation | Role |
|---|---|---|
| Robert Herman, MD, PhD | Powerful Medical | Principal Investigator |
| Emanuele Barbato, MD, PhD | University of Roma La Sapienza | Study Chair |
| Jozef Bartunek, MD, PhD | Azorg Hospital, Aalst | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Hochsteiermark, Standort Bruck | Bruck an der Mur | Austria | ||||
| LKH II Standort West |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| D054059 | Coronary Occlusion |
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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2. OMI definitions using routine angiographic and laboratory parameters will be correlated to abnormal myocardial perfusion using correlation coefficients. |
| Index hospitalization (assessed up to 5 days) |
| ECG prediction of mechanical reperfusion | a. Correlation of AI-ECG TIMI model's raw numeric predictions (between 0 and 1) with myocardial perfusion grading post PCI. | Index hospitalization (assessed up to 5 days) |
| Assessment of expert ECG interpretation blinded to all clinical information |
| Index hospitalization (assessed up to 5 days) |
| STEMI-equivalent ECG patterns | a. Prevalence of STEMI equivalent ECG patterns and their correlation to TIMI flow grade at angiography. | Index hospitalization (assessed up to 5 days) |
| Subgroup analysis of NSTEMI-OMI patients | 9. NSTEMI-OMI stratified according to immediate (<2h) vs. SoC (>2h) invasive management, median: i. Peak troponin (maximum rise before fall) ii. Median LVEF at discharge iii. Length of hospital stay iv. Length of cardiac care unit (CCU) or intensive care unit (ICU) stay v. Presence of life-threatening arrhythmias | Index hospitalization (assessed up to 5 days) |
| Graz |
| 8020 |
| Austria |
| Medical University of Graz | Graz | Austria |
| OLV Aalst | Aalst | Belgium |
| AZ Sint Jan | Bruges | Belgium |
| Jessa Ziekenhuis | Hasselt | Belgium |
| University Hospital D'Annunzio Chieti | Chieti | Italy |
| San Pietro Hospital | Rome | Italy |
| Sant´Andrea Hospital | Rome | Italy |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |