Electronic Blood Pressure Monitor for Atrial Fibrillation Detection

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood pressure monitor: In the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan).

Single-lead ECG: In the control group, a single-lead ECG will be recorded for 30s with a handheld ECG for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team.

Study summary

Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function

Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.

Study design: This study is a cluster-randomized and controlled trial.

Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria.

Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.

Sample size: About 50 centers, at least 20,000 participants.

Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026.

Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Eligibility

Primary outcome measure(s)

• The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group. — Baseline

Trial sites (1)

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