Electronic Blood Pressure Monitor for Atrial Fibrillation Detection

NCT06931288 | Not Yet Recruiting DMC

• 1 other identifier: AFSE
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Detection; Electronic blood pressure monitor

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Secondary Outcomes (1)

• The difference in detection rates atrial fibrillation of between the blood pressure monitor and the single-lead ECG group among screening-positive participants.

  Baseline

Study Arms (2)

Single-lead ECG

ACTIVE COMPARATOR

Device: Single-lead ECG

Blood pressure monitor

EXPERIMENTAL

Device: Blood pressure monitor

Interventions

Blood pressure monitor DEVICE

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).

Blood pressure monitor

Single-lead ECG DEVICE

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.

Single-lead ECG

Eligibility Criteria

• Age: 60 Years - 125 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Participants with severe communication problems.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200025

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 17, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CN (1)