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
NA
358 participants
INTERVENTIONAL
2019-06-26
2020-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Intervention
Care teams randomized to intervention will have access to the screening tool.
AI-enabled ECG-based Screening Tool
A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.
Control
Care teams randomized to control will continue routine practice.
No interventions assigned to this group
Interventions
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AI-enabled ECG-based Screening Tool
A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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 in Rochester
Rochester, Minnesota, United States
Countries
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References
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Yao X, McCoy RG, Friedman PA, Shah ND, Barry BA, Behnken EM, Inselman JW, Attia ZI, Noseworthy PA. ECG AI-Guided Screening for Low Ejection Fraction (EAGLE): Rationale and design of a pragmatic cluster randomized trial. Am Heart J. 2020 Jan;219:31-36. doi: 10.1016/j.ahj.2019.10.007. Epub 2019 Oct 25.
Barry B, Zhu X, Behnken E, Inselman J, Schaepe K, McCoy R, Rushlow D, Noseworthy P, Richardson J, Curtis S, Sharp R, Misra A, Akfaly A, Molling P, Bernard M, Yao X. Provider Perspectives on Artificial Intelligence-Guided Screening for Low Ejection Fraction in Primary Care: Qualitative Study. JMIR AI. 2022 Oct 14;1(1):e41940. doi: 10.2196/41940.
Zahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019.
Rushlow DR, Croghan IT, Inselman JW, Thacher TD, Friedman PA, Yao X, Pellikka PA, Lopez-Jimenez F, Bernard ME, Barry BA, Attia IZ, Misra A, Foss RM, Molling PE, Rosas SL, Noseworthy PA. Clinician Adoption of an Artificial Intelligence Algorithm to Detect Left Ventricular Systolic Dysfunction in Primary Care. Mayo Clin Proc. 2022 Nov;97(11):2076-2085. doi: 10.1016/j.mayocp.2022.04.008.
Yao X, Rushlow DR, Inselman JW, McCoy RG, Thacher TD, Behnken EM, Bernard ME, Rosas SL, Akfaly A, Misra A, Molling PE, Krien JS, Foss RM, Barry BA, Siontis KC, Kapa S, Pellikka PA, Lopez-Jimenez F, Attia ZI, Shah ND, Friedman PA, Noseworthy PA. Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial. Nat Med. 2021 May;27(5):815-819. doi: 10.1038/s41591-021-01335-4. Epub 2021 May 6.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-003137
Identifier Type: -
Identifier Source: org_study_id
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