A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation

NCT ID: NCT07308704

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10040000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-02-29

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.

Conditions

Cardiomyopathy; Ischemic Heart Disease; Cardiac Amyloidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Genetic cardiomyopathy arm

Transthoracic Echocardiography (TTE)

Intervention Type: DIAGNOSTIC_TEST

AI analysis of transthoracic echocardiography to improve disease detection.

Ischemic cardiomyopathy arm

Transthoracic Echocardiography (TTE)

Intervention Type: DIAGNOSTIC_TEST

AI analysis of transthoracic echocardiography to improve disease detection.

Cardiac amyloidosis arm

Transthoracic Echocardiography (TTE)

Intervention Type: DIAGNOSTIC_TEST

AI analysis of transthoracic echocardiography to improve disease detection.

Hypertrophic cardiomyopathy (HCM) arm

Transthoracic Echocardiography (TTE)

Intervention Type: DIAGNOSTIC_TEST

AI analysis of transthoracic echocardiography to improve disease detection.

Interventions

Transthoracic Echocardiography (TTE)

AI analysis of transthoracic echocardiography to improve disease detection.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tim Poterucha

Principal Invetigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim Poterucha, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Central Contacts

Tim Poterucha, M.D.

Role: CONTACT

Phone: 507-284-2129

Email: poterucha.timothy@mayo.edu

Facility Contacts

Tim Poterucha, M.D.

Role: primary

Other Identifiers

25-007929

Identifier Type: -

Identifier Source: org_study_id