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Observational Study of AI for Echo Analysis in Heart Conditions

This study is looking at how artificial intelligence (AI) can help doctors better understand echocardiograms (heart ultrasounds) and diagnose heart conditions like cardiomyopathy (a disease of the heart muscle), ischemic heart disease (heart problems caused by narrowed arteries), and cardiac amyloidosis (a condition where abnormal proteins build up in the heart). The study will use AI analysis of transthoracic echocardiography (TTE) to see if it improves disease detection. Doctors and other healthcare staff who order and interpret echocardiograms for patients aged 18 and older at Mayo Clinic sites, and whose patients have a high risk for genetic cardiomyopathy based on AI-Echo analysis, may be involved. The main goals are to see how easy the AI is for clinicians to use, if it helps them interpret results consistently, and if it fits well into their work. It also aims to see if using AI leads to more diagnostic testing and quicker diagnoses.

Study design
This is an observational study with a planned enrollment of 10,040,000 participants. It will use a stepped-wedge clinical trial design with multiple arms.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures diagnoses of genetic cardiomyopathy, obstructive coronary artery disease, and cardiac amyloidosis at baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07308704

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~10,040,000 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Transthoracic Echocardiography (TTE)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients diagnosed with genetic cardiomyopathy confirmed by genetic testing
Measured over Baseline
+3 more outcomes measured

Conditions

Cardiomyopathy
Ischemic Heart Disease
Cardiac Amyloidosis

Explore related trials

Cardiac AmyloidosisHypertrophic CardiomyopathyIschemic Heart DiseaseToxic cardiomyopathy

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Tim Poterucha, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Tim Poterucha, M.D.
[email protected]
507-284-2129
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of patients diagnosed with genetic cardiomyopathy confirmed by genetic testingBaseline

    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.

  • Number of patients diagnosed with obstructive coronary artery diseaseBaseline

    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.

  • Number of patients diagnosed with cardiac amyloidosisBaseline

    Number of patients diagnosed with cardiac amyloidosis in the cardiac amyloidosis arm confirmed by consensus criteria, both imaging- and pathology-based amyloidosis diagnostic pathways.

  • Number of patients diagnosed with hypertrophic cardiomyopathyBaseline

    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).