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

August 16, 2022 updated by: Xiaoxi Yao, Mayo Clinic

Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study aims to enroll 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BEAGLE Participants
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.
Other: AI-enabled ECG-based Screening Tool for AF
A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool to improve atrial fibrillation diagnosis and stroke prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of Atrial Fibrillation as Detected by Patch Application
Time Frame: Three Months
The data will be used to examine the performance of the algorithm in detecting unrecognized atrial fibrillation (e.g. positive predictive value, negative predictive value, sensitivity, specificity, and area under the curve [AUC]).
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Xiaoxi Yao, PhD, MPH, Mayo Clinic
  • Principal Investigator: Peter Noseworthy, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Actual)

January 27, 2022

Study Completion (Actual)

January 27, 2022

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-012411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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