ST-segment Elevation Not Associated With Acute Cardiac Necrosis (LESTONNAC)

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— LESTONNAC  

Official title:

LESTONNAC Study: Observed ST Elevation Does Not Require Acute Cardiac Necrosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05689970
• Other study ID #: 350/21
• Status: Active, not recruiting
• Start date: July 25, 2022
• Est. completion date: July 24, 2024

Study information

• Verified date: March 2024
• Source: Idoven 1903 S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: July 24, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Necrosis
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Diagnostic Test:
• AI platform to detect ST elevation in ECG
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.

Locations

Country	Name	City	State
Spain	Hospital Vall D' Hebron	Barcelona
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife
Spain	Hospital Clínico San Carlos	Madrid
Spain	Idoven	Madrid
Spain	Servicio Cardiología Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (3)

Lead Sponsor	Collaborator
Idoven 1903 S.L.	Hospital General Universitario Gregorio Marañon, Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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