Objective:Therandomizedcontrolledtrial(ClinicalTrials.govidentifierNCT02990741)willinvestigatewhethermorefrequentelectrocardiographic(ECG)recordingsandanalyseswithanautomatedECGsystemwouldimprovedetectionofatrialfibrillationcomparedwithasingleannualECGscreeninelderlyChineseincommunityhealthcenters.Design:Menandwomen(≥65years)willberandomizedintointensive(n=3500)andusual(n=3500)screeninggroups,andwithintheintensivescreeninggroupintointensivescreening(n=2625)andmoreintensivescreening(n=875)subgroups.ECGrecordingswillbeperformedwithanautomatedECGanalysissystem(AliveCorheartmonitor)at1yearintheusualscreeninggroup,at3,6,9,and12monthsintheintensivescreeningsubgroup,andat1,2,3,and4weeksand3,6,9,and12monthsinthemoreintensivescreeningsubgroup.Theprimaryoutcomeisthedetectionrateofatrialfibrillationbetweentheusualscreeninggroupandtheintensivescreeninggroup.Samplesizeestimationwasbasedonaprojecteddetectionrateofatrialfibrillationof2.0%byasingleECGrecordingat12months,animprovementof50%withmorefrequentECGrecordings,α=0.05,powerof80%,andaone-sidedtest.Conclusions:ThetrialwillprovideevidenceontheclinicaleffectivenessofmorefrequentECGrecordingsbyahandheldautomatedanalysissysteminthedetectionofatrialfibrillation.
