Rationale and Design of the Randomized Controlled Trial of Intensive Versus Usual ECG Screening for Atrial Fibrillation in Elderly Chinese by an Automated ECG System in Community Health Centers in Shanghai (AF-CATCH)

Abstract

Objective: The randomized controlled trial (ClinicalTrials.gov identifier NCT02990741) will investigate whether more frequent electrocardiographic (ECG) recordings and analyses with an automated ECG system would improve detection of atrial fibrillation compared with a single annual ECG screen in elderly Chinese in community health centers. Design: Men and women (≥65 years) will be randomized into intensive (n=3500) and usual (n=3500) screening groups, and within the intensive screening group into intensive screening (n=2625) and more intensive screening (n=875) subgroups. ECG recordings will be performed with an automated ECG analysis system (AliveCor® heart monitor) at 1 year in the usual screening group, at 3, 6, 9, and 12 months in the intensive screening subgroup, and at 1, 2, 3, and 4 weeks and 3, 6, 9, and 12 months in the more intensive screening subgroup. The primary outcome is the detection rate of atrial fibrillation between the usual screening group and the intensive screening group. Sample size estimation was based on a projected detection rate of atrial fibrillation of 2.0% by a single ECG recording at 12 months, an improvement of 50% with more frequent ECG recordings, a=0.05, power of 80%, and a one-sided test. Conclusions: The trial will provide evidence on the clinical effectiveness of more frequent ECG recordings by a handheld automated analysis system in the detection of atrial fibrillation.