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| Name | Class |
|---|---|
| Hospital General Universitario Gregorio Marañon | OTHER |
| Spanish Society of Cardiology | OTHER |
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Patients with chest pain and persistent ST segment elevation (STE) may not have acute coronary occlusions or serum troponin curves suggestive of acute necrosis. Our objective is the validation and cost-effectiveness analysis of a diagnostic model assisted by artificial intelligence (AI). Our hypothesis is that an AI analysis of the surface electrocardiogram allows a better distinction of patients with STE due to acute myocardial ischemia, from those with another etiology. This is a prospective multicenter study with two groups of patients with STE: I) coronary arteries without significant lesions and without serum troponin curve suggestive of acute necrosis, II) myocardial infarction with acute coronary occlusion. A manual centralized electrocardiographic analysis and another by AI algorithms will be performed.
This is a prospective multicenter study promoted by the Ischemic Heart Disease and Acute Cardiovascular Care Section of the Spanish Society of Cardiology. Following institutional ethical approval, the surface ECG prior to the activation of the Infarction Code, and the ECGs before and after (up to a maximum of 20) the Infarction Code along with other clinical data will be collected across the different enrolled hospitals. Sites will securely transfer the data to a centralized repository for processing. Willem AI platform will automatically analyze the ECGs in parallel to an experienced observer. The results of the study will provide new information for the improvement in the stratification of patients with ST segment elevation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STE patients | Patients with ST segment elevation (STE) and coronary arteries without significant lesions and without a serum troponin curve suggestive of acute necrosis (group without acute myocardial necrosis). |
| |
| STEMI patients | Patients with ST segment elevation with acute occlusion of at least one epicardial coronary artery and TIMI flow 0 or I (group with acute myocardial necrosis of ischemic origin), that meet the definition of myocardial infarction (STEMI) with an acute cardiac necrosis curve verified by measurement of troponin I or troponin T. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI platform to detect ST elevation in ECG | Diagnostic Test | A clinical decision support software as a medical device that detects whether a patient has ST elevation due to acute myocardial ischemia or due to another etiology based upon the input of one or more ECGs and other clinical data obtained at the point-of-care. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical validation of a screening model assisted by AI | The detection performance of acute myocardial ischemia will be evaluated for the AI platform in comparison to standard manual analysis. | 6 months after the last enrolled patient |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness analysis of a screening model assisted by AI | The benefits of the screening model assisted by the AI platform will be evaluated using a hybrid decision tree/ Markov model. | 1 year after the last enrolled patient |
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Inclusion Criteria:
Exclusion Criteria:
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Patients going to the hospital with suspected symptoms of myocardial infarction and ST segment elevation in the electrocardiogram.
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Martínez-Sellés, MD | Hospital Universitario Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18775237 | Background | Martinez-Selles M, Bueno H, Sacristan A, Estevez A, Ortiz J, Gallego L, Fernandez-Aviles F. Chest pain in the emergency department: incidence, clinical characteristics and risk stratification. Rev Esp Cardiol. 2008 Sep;61(9):953-9. English, Spanish. | |
| 31840163 | Background | Lillo-Castellano JM, Gonzalez-Ferrer JJ, Marina-Breysse M, Martinez-Ferrer JB, Perez-Alvarez L, Alzueta J, Martinez JG, Rodriguez A, Rodriguez-Perez JC, Anguera I, Vinolas X, Garcia-Alberola A, Quintanilla JG, Alfonso-Almazan JM, Garcia J, Borrego L, Canadas-Godoy V, Perez-Castellano N, Perez-Villacastin J, Jimenez-Diaz J, Jalife J, Filgueiras-Rama D. Personalized monitoring of electrical remodelling during atrial fibrillation progression via remote transmissions from implantable devices. Europace. 2020 May 1;22(5):704-715. doi: 10.1093/europace/euz331. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| PubMed ID: 34763217 | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Hospital de Basurto |
| Bilbao |
| Vizcaya |
| 48013 |
| Spain |
| Hospital Vall D' Hebron | Barcelona | 08035 | Spain |
| Idoven | Madrid | 28002 | Spain |
| Servicio Cardiología Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| 36310681 | Background | Quartieri F, Marina-Breysse M, Pollastrelli A, Paini I, Lizcano C, Lillo-Castellano JM, Grammatico A. Artificial intelligence augments detection accuracy of cardiac insertable cardiac monitors: Results from a pilot prospective observational study. Cardiovasc Digit Health J. 2022 Aug 4;3(5):201-211. doi: 10.1016/j.cvdhj.2022.07.071. eCollection 2022 Oct. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D004568 | Electrodiagnosis |