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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05923359
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Xiaoxi Yao, Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Apple Watch Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
Actual Study Start Date : April 10, 2024
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Atrial fibrillation [ Time Frame: 2 years ]
    Number of participants diagnosed with atrial fibrillation


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. Ischemic stroke or systemic embolism events [ Time Frame: 2 years ]
    Number of ischemic stroke or systemic embolism events

  4. Major bleeding [ Time Frame: 2 years ]
    Number of major bleeding events

  5. Mortality [ Time Frame: 2 years ]
    Number of participant deaths


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923359


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Xiaoxi Yao, PhD Mayo Clinic
More Information
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Responsible Party: Xiaoxi Yao, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05923359    
Other Study ID Numbers: 22-011253
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes