External validation of an artificial intelligence–based ECG algorithm for the early diagnosis of acute myocardial infarction: a prospective diagnostic cohort study

Background A novel artificial intelligence–based electrocardiogram (AI-ECG) model (AiTiA MI v2.00.00) for the early diagnosis of acute myocardial infarction (AMI) was developed using data from Korean patients. Its performance in a European population remains unknown. Methods Patients presenting to the emergency department (ED) with suspected AMI were enrolled in two prospective European cohorts (APACE & APACE-Light; ClinicalTrials.gov number, NCT00470587). The primary outcome was AMI, centrally adjudicated according to the fourth Universal Definition of MI. The AI-ECG model was applied to 12-lead ECGs recorded at ED presentation. Its diagnostic performance for AMI was directly compared to that of the BASEL score, high-sensitivity cardiac troponin T (hs-cTnT), the recalibrated HEART score (all at ED presentation), and integrated physician judgment at 90 min, with the last two only available in APACE. Predefined AI-ECG triage thresholds for early rule-out and rule-in of AMI were also evaluated. Findings Among 12,630 patients with an available digital 12-lead ECG (5047 in APACE and 7583 in APACE-Light), adjudicated AMI was diagnosed in 19% (968/5047) and 18% (1386/7583) of patients, respectively. In patients with hs-cTnT at presentation (n = 5031 and n=7565), the AI-ECG model showed good diagnostic performance for AMI with an area under the receiver operating characteristic curve (AUC) of 0.78 (95% CI: 0.77–0.80) and 0.84 (0.83–0.85) and an area under the precision–recall curve (AUPRC) of 0.56 (0.53–0.59) and 0.65 (0.62–0.67). Its discrimination was inferior to hs-cTnT (AUC 0.94 [0.93–0.95] and 0.93 [0.92–0.94]). The AI-ECG model provided some incremental diagnostic value when combined with hs-cTnT (AUC 0.95 [0.94–0.96] and 0.95 [0.94–0.95], p < 0.001). The predefined triage thresholds ruled out 14% (706/5031) and 19% (1437/7565) of patients, with a sensitivity for AMI of 97.6% (96.5–98.5) and 97.5% (96.6–98.3), respectively. Interpretation AI-ECG showed high, but not very high, diagnostic accuracy for AMI. As a diagnosis of AMI is unlikely to be ruled out on ECG alone, combining AI-ECG with hs-cTnT may improve decision making in the ED, warranting prospective studies. Funding The Swiss National Science Foundation, the Swiss Heart Foundation, Innosuisse, the University Hospital Basel, the University of Basel, Abbott, Beckman Coulter, Idorsia, LSI Medience Corporation, Roche, Ortho Clinical Diagnostics, Quidel, Siemens, SpinChip, Upstream, and Singulex, the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: RS-2026-25543703).