CardiomyopathyNCT07308704
A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation
An observational study of Cardiomyopathy and Ischemic Heart Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Ischemic Heart Disease, Cardiac Amyloidosis
- What is being tested?
- Transthoracic Echocardiography (TTE)
- How many people
- 10,040,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Tim Poterucha, M.D., 507-284-2129, poterucha.timothy@mayo.edu
Tim Poterucha, M.D.
About this study
Official title: DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB
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.
- Conditions
- Cardiomyopathy, Ischemic Heart Disease, Cardiac Amyloidosis
- Being tested
- Transthoracic Echocardiography (TTE)
- Medical subject headings
- Cardiomyopathies, Myocardial Ischemia, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Echocardiography (TTE)Diagnostic test
AI analysis of transthoracic echocardiography to improve disease detection.
| Study group | Role | What they receive |
|---|---|---|
| Genetic cardiomyopathy arm | Not described Receives: Diagnostic Test: Transthoracic Echocardiography (TTE) | |
| Ischemic cardiomyopathy arm | Not described Receives: Diagnostic Test: Transthoracic Echocardiography (TTE) | |
| Cardiac amyloidosis arm | Not described Receives: Diagnostic Test: Transthoracic Echocardiography (TTE) | |
| Hypertrophic cardiomyopathy (HCM) arm | Not described Receives: Diagnostic Test: Transthoracic Echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline
Secondary 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start26 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,040,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Poterucha, Mayo Clinic
- Investigators
- Tim Poterucha, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308704
- Sponsor's protocol ID
- 25-007929
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB
- ClinicalTrials.gov ID
- NCT07308704
- Acronym / sponsor ID
- 25-007929
- Conditions
- Cardiomyopathy, Ischemic Heart Disease, Cardiac Amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,040,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Genetic cardiomyopathy arm | – | Diagnostic Test: Transthoracic Echocardiography (TTE) |
| Ischemic cardiomyopathy arm | – | Diagnostic Test: Transthoracic Echocardiography (TTE) |
| Cardiac amyloidosis arm | – | Diagnostic Test: Transthoracic Echocardiography (TTE) |
| Hypertrophic cardiomyopathy (HCM) arm | – | Diagnostic Test: Transthoracic Echocardiography (TTE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic Echocardiography (TTE)AI analysis of transthoracic echocardiography to improve disease detection. | Diagnostic test | Cardiac amyloidosis arm, Genetic cardiomyopathy arm, Hypertrophic cardiomyopathy (HCM) arm, Ischemic cardiomyopathy arm |
Primary outcome
Number of patients diagnosed with genetic cardiomyopathy confirmed by genetic testing
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.
Number of patients diagnosed with obstructive coronary artery disease
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.
Number of patients diagnosed with cardiac amyloidosis
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.
Number of patients diagnosed with hypertrophic cardiomyopathy
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).
1 secondary outcome
Time from index TTE to confirmed diagnosis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Poterucha, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Ischemic Heart Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Poterucha, M.D. (507-284-2129, poterucha.timothy@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients diagnosed with genetic cardiomyopathy confirmed by genetic testing (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.