Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Care teams randomized to intervention will have access to the screening tool. |
|
| Control | No Intervention | Care teams randomized to control will continue routine practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-enabled ECG-based Screening Tool | Other | A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction. |
| Measure | Description | Time Frame |
|---|---|---|
| New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%) | Ejection fraction obtained by echocardiography. | Within 90 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxi Yao, PhD, MPH | Mayo Clinic | Principal Investigator |
| Peter Noseworthy, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31710842 | Background | 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. | |
| 38875550 | Derived |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 37923529 | Derived | 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. |
| 36333015 | Derived | 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. |
| 33958795 | Derived | 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. |