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

Last updated: August 18, 2020
Sponsor: Huashan Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiac Disease

Chest Pain

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT04519190
SAFE-high risk
  • Ages 18-85
  • All Genders

Study 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

Inclusion

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: 3points Imaging examination shows old cerebral infarction, transient ischemicattack(TIA), lacunar infarction with clear symptoms: 2points

  4. Congestive heart failure: Ejection fraction(EF)≥50%, N terminal pro-brain natriureticpeptide(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 coronaryintervention(PCI) or coronary artery bypass graft(CABG): 2points Clear history ofperipheral arterial obstruction: 3points

  7. Hypertension: Blood pressure controlled: 1point Blood pressure uncontrolled(Systolicblood pressure>160mmHg): 2points

  8. Diabetic mellitus: Plasma glucose level controlled:1point Plasma glucose leveluncontrolled(HBA1c>7):2points i:Chronic kidney disease: estimated glomerularfiltration rate(eGFR) 30-49: 1point eGFR <30: 2points j:Sleep apnea syndrome: 1pointk: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 toparticipate in the study

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 300
Study Start date:
August 25, 2020
Estimated Completion Date:
August 31, 2023