A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment.
Hypertrophic cardiomyopathy (HCM) arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff caring for patients aged ≥18 years who are undergoing a comprehensive TTE at a participating Mayo Clinic site, with AI-Echo analysis indicating high risk for HCM. A high-risk score will be defined by a specific threshold determined during model development to maximize sensitivity while maintaining adequate positive predictive value for clinical deployment.
Disqualifiers
Genetic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known or suspected diagnosis of genetic cardiomyopathy under evaluation, on hospice care, or who have an expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.
Ischemic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known CAD; prior myocardial infarction; revascularization with PCI or CABG; ischemic testing within the past 12 months; hospice care or expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.
Cardiac amyloidosis arm: Studies performed within the past 2 years at a Mayo site or in those patients with prior amyloid-specific testing (e.g., technetium pyrophosphate scan, cardiac MRI with late gadolinium enhancement suggestive of amyloid) or biopsy-proven systemic amyloidosis, on hospice care, or have expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.
Hypertrophic cardiomyopathy (HCM) arm: Studies performed within the past 2 years at a Mayo site or patients with a known diagnosis of HCM documented in the medical record prior to the index TTE, prior septal reduction therapy (surgical myectomy or alcohol septal ablation), or patients on hospice care or with an expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transthoracic Echocardiography (TTE)
Diagnostic testAI analysis of transthoracic echocardiography to improve disease detection.
Treatment groups
10,040,000 Participants
are divided into 4 treatment groupsGroup A: Genetic cardiomyopathy arm1 intervention
Group B: Ischemic cardiomyopathy arm1 intervention
Group C: Cardiac amyloidosis arm1 intervention
Group D: Hypertrophic cardiomyopathy (HCM) arm1 intervention
Trial outcomes
Primary outcomes
1
Number 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
Baseline2
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
Baseline3
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
Baseline4
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
BaselineSecondary outcomes
1
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
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov