Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)

April 25, 2024 updated by: Xiaoxi Yao, Mayo Clinic
The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Had a 10-second 12-lead ECG done at Mayo Clinic
  • Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized AF
  • Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3

Exclusion Criteria:

  • Diagnosed atrial fibrillation
  • Diagnosed dementia
  • Diagnosed end-stage kidney disease
  • History of intracranial bleeding
  • Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
  • Missing date of birth
  • Residence outside of the U.S. or missing address information

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apple Watch Intervention Group
Participants will be asked to wear an Apple Watch and use the Mayo Clinic ECG Study App to collect and share data with the study team.
Other: Apple Watch
Apple Watch
No Intervention: Control Group
Participants will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation
Time Frame: 2 years
Number of participants diagnosed with atrial fibrillation
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in individuals' maximum learning span
Time Frame: Baseline, 2 years
Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance. Maximum learning span is total number of words recognized.
Baseline, 2 years
Change in processing speed measure
Time Frame: Baseline, 2 years
Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses a symbols test to measure processing speed reported in average completion time (seconds).
Baseline, 2 years
Ischemic stroke or systemic embolism events
Time Frame: 2 years
Number of ischemic stroke or systemic embolism events
2 years
Major bleeding
Time Frame: 2 years
Number of major bleeding events
2 years
Mortality
Time Frame: 2 years
Number of participant deaths
2 years

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, 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.

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)

April 10, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-011253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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