Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF

Mayo Clinic

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: AI-enabled ECG-based Screening Tool for AF

Study type: Observational

Funder types: Other

Identifiers

NCT04208971

19-012411

Details and patient eligibility

About

This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.

Enrollment: 1,225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Had a 10-second 12-lead ECG done at Mayo Clinic
• Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3

Exclusion criteria

• Diagnosed atrial fibrillation or atrial flutter
• Missing date of birth or sex in the electronic health record (EHR)
• A history of intracranial bleeding
• A history of end-stage kidney disease
• Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
• Deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.

Trial design

1,225 participants in 1 patient group

BEAGLE Participants

Description:

Adult patients who have not been previously diagnosed with AF, are eligible for anticoagulation and have AI-predicted risks based on a normal sinus rhythm ECG.

Treatment:

Other: AI-enabled ECG-based Screening Tool for AF