Medical-AI trial: AI predicts one-year mortality risk from the ECG — a Software as a Medical Device validated on 462,000 records (NCT07659262)

1What ten seconds of ECG can show

An electrocardiogram (ECG) is a simple, widely available test that records the electrical activity of the heart for about ten seconds. Traditional assessment of mortality or cardiovascular risk has also used values such as blood tests, but these are not always present in the electronic health record and cannot always be computed.

The Software as a Medical Device this study validates avoids that constraint, seeking to estimate the probability of cardiac-related death within one year from the standard ECG waveform alone using AI.

2The software under evaluation

Per the registry summary, the software, the Chang Gung ECG Mortality Risk Prediction Software, is an AI-based Software as a Medical Device (SaMD) that analyzes a standard 10-second, 12-lead resting ECG signal to predict the probability of cardiac-related mortality within one year.

The study validates it in a multicenter retrospective cohort, with the primary outcome being the area under the ROC curve (AUC) for predicting one-year cardiac-related mortality. The scale used for validation is large, at 461,982 records.

3The scale of 460,000 records

The scale used for validation here stands out among the trials this site holds. Placed in the distribution, the size becomes clear.

Risk assessment for death and cardiovascular events has drawn on blood tests, which are not always present in the record. Estimating risk from an ECG alone, obtainable anywhere, would give a handle on identifying high-risk people where testing facilities are thin. A risk prediction remains a probability.