Study protocol for The Heart Watch Study - Prognostic performance of smartwatch 12-lead ECG with advanced ECG analysis in consumer self-screening for cardiovascular disease
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Background
It is now possible to acquire a fully diagnostic standard 12-lead electrocardiography (ECG) using a smartwatch, a smartphone app, and no additional hardware. This study aims to evaluate the predictive performance of advanced ECG (A-ECG) analysis applied to a smartwatch 12-lead ECG (SWECG) acquired using an Apple Watch in identifying cardiovascular risks among asymptomatic adults performing consumer self-screening in the general population.
Methods and Design
The Heart Watch Study is a prospective, Australia-wide observational cohort study. We aim to recruit 30,000 asymptomatic participants aged 20-79 years without prior known cardiovascular disease.
Participants will enrol and consent electronically, and download a dedicated study iPhone app that enables a directed 12-lead SWECG acquisition using their Apple Watch. The recordings will undergo both conventional and A-ECG analysis. Follow-up will be performed through linkage with administrative health datasets in Australia, including hospital visits and mortality records. The primary combined endpoint is all-cause mortality, hospitalization for cardiovascular causes and incident cardiovascular disease (arrythmia, ischemic heart disease, heart failure) as predicted by A-ECG analysis.
Conclusion
This study evaluates the feasibility of performing a fully diagnostic standard 12-lead SWECG using only a smartwatch and a smartphone application, and addresses the prognostic value of A-ECG machine-learning based analysis in consumer self-screening in a large, diverse and apparently healthy population.
