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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Prolonged continuous single-lead ECG monitor; Diagnostic test: Intermittent ECG monitor; Diagnostic test: Routine practice

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Xiufang Gao, PhD; Phone Number: +8613788908071; Email: sophiakao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

We created a score system as to predict AF risk.

1. Age ≥ 75: 2points Age between 65-74: 1point
2. Male: 1point
3. Stroke: Typical symptoms of acute stroke with multiple foci on imaging examination: 5points Typical symptoms of acute stroke with single or uncertain lesion on imaging: 3 points Imaging examination shows old cerebral infarction, transient ischemic attack(TIA), lacunar infarction with clear symptoms: 2points
4. Congestive heart failure: Ejection fraction(EF)≥50%, N terminal pro-brain natriuretic peptide(NT pro-BNP)>1500 pg/mL: 1point EF 40-49%: 2points EF<40%: 4points
5. Echocardiography: Mitral stenosis or regurgitation, aortic stenosis or regurgitation: moderate degree and above: 2points Left atrial anterior-posterior diameter: 40-49mm: 1point Left atrial anterior-posterior diameter: ≥50mm: 2points
6. Vascular disease: History of myocardial infarction, percutaneous coronary intervention(PCI) or coronary artery bypass graft(CABG): 2points Clear history of peripheral arterial obstruction: 3points
7. Hypertension: Blood pressure controlled: 1point Blood pressure uncontrolled(Systolic blood pressure>160mmHg): 2points
8. Diabetic mellitus: Plasma glucose level controlled:1point Plasma glucose level uncontrolled(HBA1c>7):2points i:Chronic kidney disease: estimated glomerular filtration rate(eGFR) 30-49: 1point eGFR <30: 2points j:Sleep apnea syndrome: 1point k:Chronic obstructive pulmonary disease: 1point l:Thyroid disease: 1point

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 25, 2020
• Primary Completion (ANTICIPATED): August 31, 2023
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: August 15, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (ACTUAL): August 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SAFE-high risk

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No