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

NCT04519190 | Unknown

• 1 other identifier: SAFE-high risk
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of participates with AF episodes identified using continuous ECG monitoring compared to routine practice.

  Some atrial fibrillation patients may be left undiagnosed by routine practice due to several reasons. On ECG, AF episodes are defined as irregularly irregular QRS complex with disappearance of P wave that last over 30 seconds. A routine ECG examination may not able to capture AF episodes, however, by monitoring the subjects' cardiac rhythm continuously for a prolonged time period, we can detect asymptomatic AF episodes with higher sensitivity that would have been missed. And by further analyzing the detection rates of different monitoring periods, we can find out the most cost-effective monitoring duration and pattern.

  2020-2023

Interventions

Prolonged continuous single-lead ECG monitor DIAGNOSTIC_TEST

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

Intermittent ECG monitor DIAGNOSTIC_TEST

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.

Routine practice DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who holds several risk factors for AF but not yet diagnosed.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiufang Gao, PhD

CONTACT

+8613788908071; sophiakao@126.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physian

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 19, 2020
• Study Start: August 25, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 19, 2020

Record last verified: 2020-08