A Study of Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05923359

Collaborator

(none)

2,000

Enrollment

Location

Arms

Anticipated Duration (Months)

55.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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.

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

Primary Outcome Measures

Atrial fibrillation [2 years]
Number of participants diagnosed with atrial fibrillation

Secondary Outcome Measures

Change in individuals' maximum learning span [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.
Change in processing speed measure [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).
Ischemic stroke or systemic embolism events [2 years]
Number of ischemic stroke or systemic embolism events
Major bleeding [2 years]
Number of major bleeding events
Mortality [2 years]
Number of participant deaths

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Xiaoxi Yao, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Xiaoxi Yao, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05923359

Other Study ID Numbers:

22-011253

First Posted:

Jun 28, 2023

Last Update Posted:

Jun 28, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Jun 28, 2023