Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF
NCT ID: NCT04208971
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1225 participants
OBSERVATIONAL
2020-11-02
2022-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Had a 10-second 12-lead ECG done at Mayo Clinic
* Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Xiaoxi Yao
Principal Investigator
Principal Investigators
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Xiaoxi Yao, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Peter Noseworthy, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Noseworthy PA, Attia ZI, Behnken EM, Giblon RE, Bews KA, Liu S, Gosse TA, Linn ZD, Deng Y, Yin J, Gersh BJ, Graff-Radford J, Rabinstein AA, Siontis KC, Friedman PA, Yao X. Artificial intelligence-guided screening for atrial fibrillation using electrocardiogram during sinus rhythm: a prospective non-randomised interventional trial. Lancet. 2022 Oct 8;400(10359):1206-1212. doi: 10.1016/S0140-6736(22)01637-3. Epub 2022 Sep 27.
Yao X, Attia ZI, Behnken EM, Walvatne K, Giblon RE, Liu S, Siontis KC, Gersh BJ, Graff-Radford J, Rabinstein AA, Friedman PA, Noseworthy PA. Batch enrollment for an artificial intelligence-guided intervention to lower neurologic events in patients with undiagnosed atrial fibrillation: rationale and design of a digital clinical trial. Am Heart J. 2021 Sep;239:73-79. doi: 10.1016/j.ahj.2021.05.006. Epub 2021 May 24.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-012411
Identifier Type: -
Identifier Source: org_study_id
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