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

N/AActive Not RecruitingNCT05923359

Mayo Clinic2,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,000

Conditions

Atrial Fibrillation

Interventions

Apple WatchOTHER

Apple Watch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Atrial fibrillation

Number of participants diagnosed with atrial fibrillation

Time frame: 2 years

Secondary Outcomes

Change in individuals' maximum learning span

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.

Time frame: Baseline, 2 years

Change in processing speed measure

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).

Time frame: Baseline, 2 years

Ischemic stroke or systemic embolism events

Number of ischemic stroke or systemic embolism events

Time frame: 2 years

Major bleeding

Number of major bleeding events

Time frame: 2 years

Mortality

Number of participant deaths

Time frame: 2 years

Data from ClinicalTrials.gov

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