Screening for Atrial Fibrillation With Prolonged Continuous Single-lead ECG Devices in High-risk Patients

NCT ID: NCT04519190

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2023-08-31

Brief Summary

Atrial fibrillation(AF) can be asymptomatic and thus left unidentified in many people, but holds potential risk of lethal complications such as stroke and congestive heart failure. With different screening strategy, the screening result will be different. The longer the monitoring period is, the higher chances AF episodes can be identified, but with greater cost and lower compliance. Therefore, in this study, the investigators want to find the most cost-effective method for AF screening in high risk population with prolonged continuous single-lead ECG device.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Prolonged continuous single-lead ECG monitor

We use Smartpatch, a listed ambulatory electrocardiographic system that can continuously record and save patients' cardiac rhythm for up to 45 days.

Intervention Type: DIAGNOSTIC_TEST

Intermittent ECG monitor

When using Smartpatch, we can set time markers by pressing the button on the device. We ask our subjects to press that button twice a day and also when they feel any discomfort. Analyzing the ECG 1 minute after those time markers can serve as a surrogate for intermittent ECG monitor.

Intervention Type: DIAGNOSTIC_TEST

Routine practice

Perform pulse palpation and also ECG if irregular rhythm is found.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 1.Age between 18-85 2.Score ≥5points in the above scoring system 3.Volunteer to participate in the study

Exclusion Criteria

• 1.Clear history of atrial flutter or atrial fibrillation 2.History of pacemaker implacement 3.Already on anticoagulation therapy 4.History of severe contact dermatitis 5.ECG recorded by our device unrecognizable 6.Patients with end-stage disease or at advanced stage of cancer with life expectancy less than 1 year

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiufang Gao

Associate chief physian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xiufang Gao, PhD

Role: CONTACT

sophiakao@126.com

+8613788908071

Other Identifiers

SAFE-high risk

Identifier Type: -

Identifier Source: org_study_id