Clinical trial NCT06931288: Electronic Blood Pressure Monitor for Atrial Fibrillation Detection
Official title: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor With Atrial Fibrillation Detection Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation
Detection
Electronic blood pressure monitor
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 20000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The eligible center as a cluster will be randomly assigned to either the single-lead ECG group or the electronic blood pressure monitor group for atrial fibrillation detection.
Primary purpose: SCREENING

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.

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

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 criteria: Inclusion Criteria:

1. Signed and dated informed consent form.
2. Age ≥ 60 years.
3. Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally.

Exclusion Criteria:

1. Participants with severe communication problems.

Primary outcomes:
measure: The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group.
timeFrame: Baseline
Secondary outcomes:
measure: The difference in detection rates atrial fibrillation of between the blood pressure monitor and the single-lead ECG group among screening-positive participants.
timeFrame: Baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200025
state: Shanghai
Study officials:
References: