Tests AI tools that help read heart ultrasound scans for heart disease
Tests AI tools to help read heart ultrasound scans in adults with heart disease.
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Registry title
- A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation
- Status
- Recruiting
- People taking part
- 10,040,000 people, planned
- Started
- 26 Feb 2026
- Expected to end
- Feb 2028
- Type of study
- Observational, 4 groups
- Treatments tested
- Transthoracic Echocardiography (TTE)
- Record updated
- 16 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for clinicians (doctors and allied health staff) who order, perform and read echocardiograms, caring for adults whose echo AI analysis shows high risk of a heart disease.
- Age
- Patients are 18 years or older. Clinicians' age is not stated.
- Sex
- All sexes can join.
- Disease stage
- Patients have an echocardiogram (TTE) where the AI flags high risk for genetic cardiomyopathy, ischemic cardiomyopathy, cardiac amyloidosis or hypertrophic cardiomyopathy (HCM).
- Earlier treatment
- Depends on the arm. Examples of exclusions: prior heart attack, PCI or CABG, septal reduction therapy, or amyloid-specific testing.
- Biomarker or test result
- A high-risk score from the AI echo analysis, using a threshold set during model development.
Main reasons for not taking part
- Echo studies done at a Mayo site within the past 2 years
- Known or already diagnosed disease for that arm (for example known CAD or known HCM)
- Hospice care or expected non-cardiac life expectancy under 1 year
- Opted out of institutional and state research authorizations
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Genetic cardiomyopathy arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE at a participating Mayo Clinic site with AI-Echo analysis indicating high risk for a genetic cardiomyopathy. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment
- Ischemic cardiomyopathy arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE with AI-Echo analysis indicating high risk for ischemic cardiomyopathy. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment
- Cardiac amyloidosis arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE with AI-Echo analysis indicating high risk for cardiac amyloidosis. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment
- Hypertrophic cardiomyopathy (HCM) arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff caring for patients aged ≥18 years who are undergoing a comprehensive TTE at a participating Mayo Clinic site, with AI-Echo analysis indicating high risk for HCM. A high-risk score will be defined by a specific threshold determined during model development to maximize sensitivity while maintaining adequate positive predictive value for clinical deployment
Who cannot take part
- Ischemic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known CAD; prior myocardial infarction; revascularization with PCI or CABG; ischemic testing within the past 12 months; hospice care or expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations
- Cardiac amyloidosis arm: Studies performed within the past 2 years at a Mayo site or in those patients with prior amyloid-specific testing (e.g., technetium pyrophosphate scan, cardiac MRI with late gadolinium enhancement suggestive of amyloid) or biopsy-proven systemic amyloidosis, on hospice care, or have expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations
- Hypertrophic cardiomyopathy (HCM) arm: Studies performed within the past 2 years at a Mayo site or patients with a known diagnosis of HCM documented in the medical record prior to the index TTE, prior septal reduction therapy (surgical myectomy or alcohol septal ablation), or patients on hospice care or with an expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations
- Genetic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known or suspected diagnosis of genetic cardiomyopathy under evaluation, on hospice care, or who have an expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations
Where in United States
- Mayo ClinicRochester, United StatesContact: Tim Poterucha, M.D.Taking people
About the trial
What the trial wants to find out
The purpose of this study is to deploy and evaluate informational AI-Echo algorithms that assist echo clinicians in interpreting core echocardiographic parameters (e.g., LV/RV size and function, valvular disease severity) and stratifying disease progression risk. The primary outcome is clinician usability, interpretive consistency, and workflow integration. Second, we will conduct a pragmatic, stepped-wedge clinical trial with multiple arms evaluating diagnostic AI-Echo algorithms designed to identify specific cardiovascular diseases- such as genetic cardiomyopathy, ischemic heart disease, and cardiac amyloidosis-and assess whether AI deployment increases diagnostic testing and shortens time to diagnosis. Trials will be conducted using EHR-based notification systems with cluster-level randomization.
The 4 groups in the trial
- Genetic cardiomyopathy arm
Treatment: Transthoracic Echocardiography (TTE)
- Ischemic cardiomyopathy arm
Treatment: Transthoracic Echocardiography (TTE)
- Cardiac amyloidosis arm
Treatment: Transthoracic Echocardiography (TTE)
- Hypertrophic cardiomyopathy (HCM) arm
Treatment: Transthoracic Echocardiography (TTE)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB
- Plain-language title
- Tests AI tools that help read heart ultrasound scans for heart diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 16 April 2026