AI-ECG for One-Year Mortality Risk Prediction

Cardiovascular disease (CVD) remains one of the leading causes of death worldwide. While the electrocardiogram (ECG) is a standard, widely accessible tool for cardiovascular screening, traditional risk assessment models often rely heavily on blood test results, which may be unavailable in electronic health records (EHRs). To address this limitation, the Chang Gung ECG Mortality Risk Prediction Software, an artificial intelligence (AI)-based Software as a Medical Device (SaMD), was developed. The software analyzes standard 10-second, 12-lead resting ECG signals to predict the probability of cardiac-related mortality within one year. This study is a multicenter retrospective cohort study designed to validate the clinical performance of the AI software. Researchers will analyze retrospectively collected ECG data from patients aged 20 years or older with suspected cardiovascular disease across three hospitals in Taiwan. The AI model's predictions will be compared with the actual one-year mortality outcomes documented in the patients' medical records. The primary objective is to determine whether the AI model can accurately and consistently stratify patients according to their risk of cardiac-related mortality (e.g., heart failure, arrhythmia, and myocardial infarction), with an area under the receiver operating characteristic curve (AUC) greater than 0.80. The software is intended to serve as a clinical decision-support tool for long-term risk stratification in non-acute clinical settings, thereby assisting physicians in clinical decision-making and long-term patient management.

Inclusion Criteria: * Adults aged 20 years and older. * Patients who underwent a 12-lead resting electrocardiogram (ECG). * ECG records must meet the software input specifications: 12 leads, a sampling rate of 500 Hz, a 60-Hz Alternating Current (AC) filter, a recording duration of 10 seconds, and Extensible Markup Language (XML) file format. * Only the first eligible 12-lead ECG record from each patient will be included to avoid intra-individual bias. Exclusion Criteria: * ECG records with missing leads. * Cases with missing demographic information (e.g., age, sex, or mortality status) or incomplete clinical diagnostic data. * ECG records that do not meet the software input specifications (e.g., an incorrect sampling rate, AC filter setting, recording duration, or file format). * Pregnant women and patients with implanted pacemakers..