Clinical trial NCT05689970: ST-segment Elevation Not Associated With Acute Cardiac Necrosis (LESTONNAC)
Official title: LESTONNAC Study: Observed ST Elevation Does Not Require Acute Cardiac Necrosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: ST segment elevation
Artificial intelligence
Electrocardiogram
Acute myocardial infarction
Lead sponsor: Idoven 1903 S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital General Universitario Gregorio Marañon
name: Spanish Society of Cardiology
First posted: 2023-01-19
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients going to the hospital with suspected symptoms of myocardial infarction and ST segment elevation in the electrocardiogram.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age≥18 years.
* Chest pain or symptoms suggestive of myocardial ischemia.
* STE at point J in the12-lead electrocardiogram prior to activation of the infarction code in two contiguous leads ≥0.1 mV, in V2 and V3 ≥0.2 mV.
* Signature of informed consent.

Exclusion Criteria:

* Left bundle branch block.
* Acute cardiac necrosis in the absence of significant epicardial coronary artery stenosis \>70% (vasospasm, takotsubo stress cardiomyopathy, myocarditis, coronary artery dissection, acute myocardial infarction without obstructive coronary lesions - MINOCA).
* STE≤0.1 mV with pathologic Q wave suggestive of previous chronic infarction.
* Severe anemia (hemoglobin \<8.0 g/dl).

Primary outcomes:
measure: Clinical validation of a screening model assisted by AI
timeFrame: 6 months after the last enrolled patient
Secondary outcomes:
measure: Cost-effectiveness analysis of a screening model assisted by AI
timeFrame: 1 year after the last enrolled patient
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Vall D' Hebron
city: Madrid
country: Spain
facility: Idoven
city: Madrid
country: Spain
facility: Servicio Cardiología Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Hospital Universitario Gregorio Marañón
name: Manuel Martínez-Sellés, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.