Deep learning to analyze and track echocardiograms
DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB
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 type | Observational |
|---|---|
| Enrollment | 10040000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07308704 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Tim Poterucha, M.D. — Mayo Clinic
- Study coordinator: Tim Poterucha, M.D.
- Email: poterucha.timothy@mayo.edu
- Phone: 507-284-2129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.