RecruitingNot Applicable

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

United States10,040,000 participantsStarted 2026-02-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 determine…

What they're measuring

Number of patients diagnosed with genetic cardiomyopathy confirmed by genetic testing

Timeframe: Baseline

Number of patients diagnosed with obstructive coronary artery disease

Timeframe: Baseline

Number of patients diagnosed with cardiac amyloidosis

Timeframe: Baseline

Number of patients diagnosed with hypertrophic cardiomyopathy

Timeframe: Baseline

Trial details

NCT IDNCT07308704

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02

Contact for this trial

Tim Poterucha, M.D.

507-284-2129 poterucha.timothy@mayo.edu

View on ClinicalTrials.gov More Cardiomyopathy trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of patients diagnosed with genetic cardiomyopathy confirmed by genetic testing

Timeframe: Baseline

Number of patients diagnosed with obstructive coronary artery disease

Timeframe: Baseline

Number of patients diagnosed with cardiac amyloidosis

Timeframe: Baseline

Number of patients diagnosed with hypertrophic cardiomyopathy

Timeframe: Baseline