NCT07308704 A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation
| NCT ID | NCT07308704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,040,000 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,040,000 participants in total. It began in 2026-02-26 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Tim Poterucha, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07308704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07308704 currently recruiting?
Yes, NCT07308704 is actively recruiting participants. Contact the research team at poterucha.timothy@mayo.edu for enrollment information.
Where is the NCT07308704 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07308704 clinical trial?
NCT07308704 is sponsored by Mayo Clinic. The principal investigator is Tim Poterucha, M.D. at Mayo Clinic. The trial plans to enroll 10,040,000 participants.