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.
Study Type
OBSERVATIONAL
Enrollment
10,040,000
AI analysis of transthoracic echocardiography to improve disease detection.
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGNumber of patients diagnosed with genetic cardiomyopathy confirmed by genetic testing
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
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
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
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
Time from index TTE to confirmed diagnosis of hypertrophic cardiomyopathy, cardiac amyloidosis, obstructive coronary artery disease, or genetic cardiomyopathy. Measured in days.
Time frame: Baseline
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