Clinical trial NCT04519190: Screening for Atrial Fibrillation With Prolonged Continuous Single-lead ECG Devices in High-risk Patients
Official title: Screening for Atrial Fibrillation With Prolonged Continuous Single-lead ECG Devices in High-risk Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who holds several risk factors for AF but not yet diagnosed.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participates with AF episodes identified using continuous ECG monitoring compared to routine practice.
timeFrame: 2020-2023
Secondary outcomes:
Other outcomes:
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Study officials:
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