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

What this Trial Is About

Researchers are evaluating the use of advanced AI-Echo algorithms to assist clinicians in interpreting echocardiograms, focusing on key heart parameters like size, function, and valve disease severity. The study aims to improve consistency among clinicians, workflow integration, and risk stratification for diseases such as genetic cardiomyopathy, ischemic heart disease, cardiac amyloidosis, and hypertrophic cardiomyopathy. This observational trial is sponsored by the Mayo Clinic and uses real-world data and EHR-based notifications for deployment. The study involves multiple arms targeting specific heart conditions, where AI analyzes transthoracic echocardiography TTE images to identify patients at high risk for these diseases. Clinicians order and interpret comprehensive TTEs enhanced by AI, and the study compares diagnostic testing rates and time to diagnosis across groups. Cluster-level randomization is used for implementation, with high-risk thresholds set to maximize sensitivity and predictive value. Participants are adults aged 18 years or older undergoing comprehensive TTEs at Mayo Clinic sites. The study measures outcomes including the number of patients diagnosed with the specific heart conditions confirmed by testing and the time from initial echo to diagnosis. Researchers track clinician usability and diagnostic consistency, integrating AI tools into clinical workflows to assess impact on patient care over the trial duration ending in 2028.

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