Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Tim Poterucha, M.D.
CONTACT
Tim Poterucha, M.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07308704
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Tim Poterucha, M.D.
CONTACT
Tim Poterucha, M.D.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AI analysis of transthoracic echocardiography to improve disease detection.
Time frame: Baseline
Number of patients in the genetic cardiomyopathy arm who have a confirmed diagnosis of genetic cardiomyopathy based on genetic testing. Confirmation requires identification of a pathogenic or likely pathogenic variant in a cardiomyopathy-associated gene.
Time frame: Baseline
Number of patients diagnosed with obstructive coronary artery disease in the ischemic cardiomyopathy arm, defined as ≥70% stenosis in any epicardial vessel, ≥50% in the left main coronary artery on coronary CTA or invasive angiography, or evidence of ≥3 ischemic myocardial segments on stress testing or high-risk perfusion features such as transient ischemic dilation.
Time frame: Baseline
Number of patients diagnosed with cardiac amyloidosis in the cardiac amyloidosis arm confirmed by consensus criteria, both imaging- and pathology-based amyloidosis diagnostic pathways.
Time frame: Baseline
Number of patients diagnosed with hypertrophic cardiomyopathy in the hypertrophic cardiomyopathy (HCM) arm according to standard guideline-based criteria (e.g., unexplained LV wall thickness ≥15 mm, or ≥13 mm in first-degree relatives, in the absence of other causes of hypertrophy).
Time frame: Baseline
Time from index TTE to confirmed diagnosis of hypertrophic cardiomyopathy, cardiac amyloidosis, obstructive coronary artery disease, or genetic cardiomyopathy. Measured in days.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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