Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor With Atrial Fibrillation Detection Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20,000
- Locations
- 1
- Primary Endpoint
- The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group.
Study Overview
Brief 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.
Detailed Description
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function
Rationale: With the advancement of technology and the development of artificial intelligence, it has become possible to detect atrial fibrillation during routine blood pressure measurements. Previous studies have explored the accuracy of the blood pressure monitor for atrial fibrillation detection. However, the efficiency and adherence of using this device for large-scale population screening remain unknown.
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. The eligible center as a cluster will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.
Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria. Inclusion criteria included: 1) Signed and dated informed consent form. 2) Age ≥ 60 years. 3) Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally. The only exclusion criteria is severe communication problem.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 125 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed and dated informed consent form.
- •Age ≥ 60 years.
- •Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally.
Exclusion Criteria
- •Participants with severe communication problems.
Arms & Interventions
Single-lead ECG
Intervention: Single-lead ECG (Device)
Blood pressure monitor
Intervention: Blood pressure monitor (Device)
Outcomes
Primary Outcomes
The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group.
Time Frame: Baseline
Secondary Outcomes
- The difference in detection rates atrial fibrillation of between the blood pressure monitor and the single-lead ECG group among screening-positive participants.(Baseline)
Investigators
Ji-Guang Wang
Director of the Shanghai Institute of Hypertension
Ruijin Hospital