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Recruiting NCT05689970

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

Conditions: STEMI - ST Elevation Myocardial Infarction

Sex: All
Ages: 18 Years – N/A
Enrollment: 420
Sponsor: Idoven 1903 S.L.

Location: Spain

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.

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05689970). StuddyBuddy aggregates publicly available trial information.