Clinical trial Recruiting at 1 site Observational Ages 18 and up

Deep learning to analyze and track echocardiograms

Official title: DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB

Run by Mayo Clinic · NCT07308704 · Data updated 2026-11-12

This project will test AI tools that help clinicians read echocardiograms and flag adults who may have genetic cardiomyopathy, ischemic heart disease, or cardiac amyloidosis to see if interpretation improves and diagnoses happen faster.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment10040000 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedFebruary 26, 2026
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedApril 16, 2026
Trial IDNCT07308704 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (age ≥18) undergoing a comprehensive transthoracic echocardiogram at a participating Mayo Clinic site whose echoes are processed by the AI and may be flagged as high risk for genetic cardiomyopathy, ischemic heart disease, or cardiac amyloidosis, along with the clinicians who order and interpret those studies.

Probably not a fit

Patients under 18, those receiving limited or noncomprehensive echocardiograms, patients at nonparticipating sites, or those with nondiagnostic echo images are unlikely to receive direct benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study deploys informational AI-Echo algorithms at Mayo Clinic to assist clinicians with core echocardiographic measures (for example, LV/RV size and function and valvular disease severity) and to stratify disease progression risk, with primary outcomes of clinician usability, interpretive consistency, and workflow integration. In a second phase, the team will run a pragmatic stepped-wedge, cluster-randomized trial with multiple arms testing diagnostic AI models that identify patients at high risk for genetic cardiomyopathy, ischemic heart disease, or cardiac amyloidosis. The trial uses EHR-based notifications to clinicians and measures whether AI deployment increases diagnostic testing and shortens time to diagnosis. High-risk thresholds for each disease were set during model development to prioritize sensitivity while maintaining an adequate positive predictive value for clinical use.

Why it matters

Potential benefit: If successful, patients could receive more consistent echo interpretations and faster diagnosis of serious cardiomyopathies, enabling earlier follow-up and treatment.

How similar studies have gone: Prior retrospective and diagnostic studies applying AI to echocardiography have shown promising gains in measurement consistency and disease detection, but pragmatic, randomized implementation studies are still relatively uncommon.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria:

* 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.

Exclusion criteria:

* 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.
* 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.

Where it's running

  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.