Asymptomatic Left Ventricular Systolic Dysfunction (Disorder)EAGLENCT04000087
ECG AI-Guided Screening for Low Ejection Fraction
A study testing AI-enabled ECG-based Screening Tool in people with Asymptomatic Left Ventricular Systolic Dysfunction (Disorder) and Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Left Ventricular Systolic Dysfunction (Disorder), Heart Failure
- What is being tested?
- AI-enabled ECG-based Screening Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2019to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care clinicians who are part of a participating care team that care for adult patients and have the ability to order ECG and TTE (this includes physicians, nurse practitioners, and physician assistants).
Who cannot join
- Primary care clinicians working in pediatrics, acute care, nursing homes, and resident care teams.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE)
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.
- Being tested
- AI-enabled ECG-based Screening Tool
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled ECG-based Screening ToolOther
A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Care teams randomized to intervention will have access to the screening tool. Receives: Other: AI-enabled ECG-based Screening Tool |
| Control | No intervention | Care teams randomized to control will continue routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%)
Ejection fraction obtained by echocardiography.
Measured: Within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start26 Jun 2019
- Primary completion31 Mar 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic Left Ventricular Systolic Dysfunction (Disorder)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoxi Yao, Mayo Clinic
- Investigators
- Xiaoxi Yao, PhD, MPH, Principal investigator, Mayo ClinicPeter Noseworthy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000087
- Sponsor's protocol ID
- 19-003137
- Acronym
- EAGLE
- Status last verified
- May 2023
- First submitted
- 24 Jun 2019
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31710842Barry 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.
PubMed 38875550Zahrieh 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.
PubMed 37923529Rushlow 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.
PubMed 36333015Yao 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.
PubMed 33958795
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE)
- ClinicalTrials.gov ID
- NCT04000087
- Acronym / sponsor ID
- EAGLE / 19-003137
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AI-enabled ECG-based Screening ToolCare teams randomized to intervention will have access to the screening tool. |
| Control | No intervention | –Care teams randomized to control will continue routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care clinicians who are part of a participating care team that care for adult patients and have the ability to order ECG and TTE (this includes physicians, nurse practitioners, and physician assistants).
Key exclusion criteria (1 listed)
- Primary care clinicians working in pediatrics, acute care, nursing homes, and resident care teams.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-enabled ECG-based Screening ToolA novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction. | Other | Intervention |
Primary outcome
New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%)
Time frame: Within 90 days
Ejection fraction obtained by echocardiography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 31710842Yao 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.
- Derived from this study: PubMed 38875550Barry 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.
- Derived from this study: PubMed 37923529Zahrieh 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.
- Derived from this study: PubMed 36333015Rushlow 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.
- Derived from this study: PubMed 33958795Yao 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoxi Yao, PhD, MPH principal investigator
Mayo Clinic
Peter Noseworthy, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enabled ECG-based Screening Tool in people with Asymptomatic Left Ventricular Systolic Dysfunction (Disorder) and Heart Failure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%) (time frame: Within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000087, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.