Actively Recruiting
DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB
Led by Mayo Clinic · Updated on 2026-04-16
10040000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinicians ordering, performing, and interpreting echocardiograms for patients aged 18 years or older undergoing comprehensive transthoracic echocardiography (TTE) at Mayo Clinic sites
- Patients identified by AI-Echo analysis as high risk for genetic cardiomyopathy, ischemic cardiomyopathy, cardiac amyloidosis, or hypertrophic cardiomyopathy based on defined thresholds
- Clinicians include physicians and allied health staff involved in patient care and echocardiogram interpretation
You will not qualify if you...
- Patients with echocardiograms performed within the past 2 years at a Mayo site for the same condition
- Patients with known or suspected diagnosis of the specific heart condition under evaluation
- Patients receiving hospice care or with expected non-cardiac life expectancy less than 1 year
- Patients who have opted out of institutional and state research authorizations
- For ischemic cardiomyopathy arm: prior myocardial infarction, revascularization procedures, or ischemic testing within the past 12 months
- For cardiac amyloidosis arm: prior amyloid-specific testing or biopsy-proven systemic amyloidosis
- For hypertrophic cardiomyopathy arm: prior septal reduction therapy or documented diagnosis before the index TTE
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment at baseline
Participants undergo transthoracic echocardiography (TTE) analyzed by AI to identify high risk for specific cardiomyopathies.
1 visit (in-person)
Duration - Up to study completion in February 2028
Participants are monitored over time to track diagnoses confirmed by genetic testing or other clinical evaluations.
Follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
T
Tim Poterucha, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here