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DELINEATE-Prospective

Deep Learning for Echo Analysis, Tracking, and Evaluation Prospective Evaluation (DELINEATE-Prospective)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07197736
Acronym
DELINEATE
Enrollment
50
Registered
2025-09-29
Start date
2026-04-15
Completion date
2028-10-01
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Regurgitation, Aortic Stenosis, Mitral Regurgitation (MR), Tricuspid Regurgitation (TR), Valve Disease, Aortic, Valvular Heart Disease

Keywords

artificial intelligence, deep learning, valvular heart disease, echocardiography, cardiovascular disease, mitral regurgitation, aortic stenosis

Brief summary

Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease. Valve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers. Recent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions. At Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.

Detailed description

In a prior Columbia University study, a series of deep learning algorithms analyzing echocardiograms is in development. These algorithms include, but are not limited to, algorithms that enable view classification, structure identification, left ventricle (LV) dimension measurements, Left Ventricular Ejection Fraction (LVEF) determination, left atrium (LA) volume assessments, and valvular heart disease diagnosis. Briefly, these algorithms are based on architectures shown to be useful in image and video analysis, including ones specific to echocardiography interpretation. Algorithms based off these architectures can be generalized to interpretation of video-based echocardiogram data such as valvular regurgitation assessment. As part of this study protocol, these models will continue to be developed using patient echocardiogram data. This study aims to create an automated, end-to-end system that can deliver deep learning analyses of echocardiograms to the interpreting cardiologist in real-time. If successful, this program could enable improvements in echocardiography reading efficiency and reliability.

Interventions

None listed

Sponsors

Columbia University
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Attending cardiologist employed by Columbia University, ColumbiaDoctors, or NewYork Presbyterian Hospital who reads transthoracic echocardiograms in the Columbia echocardiography laboratory * Provided informed consent to take part in the questionnaires or pivotal study

Exclusion criteria

* Physician in training (cardiology fellow or advanced imaging fellow)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Clinically Meaningful Reclassification by Panel Review18 monthsProportion of cases where the expert panel reclassifies valvular regurgitation severity by at least one grade (upgrade or downgrade). The proportion will be calculated as the number of cases with reclassification ÷ total number of cases reviewed.

Secondary

MeasureTime frameDescription
Proportion of Cases with AI-Based Reclassification Leading to a Change in Clinical Management18 monthsThe proportion will be calculated as the number of cases with any management change ÷ total number of cases reviewed.
Proportion of Cases with AI-Based Reclassification Leading to Referral to a Valve Specialist or Surgeon18 monthsDefinition: The proportion will be calculated as the number of cases referred to a valve specialist or surgeon ÷ total number of cases reviewed.
Proportion of Cases with AI-Based Reclassification Leading to a Change in Frequency of Follow-Up Echocardiography18 monthsThe proportion will be calculated as the number of cases with a change in recommended follow-up echocardiography frequency ÷ total number of cases reviewed.
Proportion of Cases with AI-Based Reclassification Leading to Referral for Further Testing (TEE or Cardiac MRI)18 monthsThe proportion will be calculated as the number of cases referred for further testing with TEE or cardiac MRI ÷ total number of cases reviewed.

Countries

United States

Contacts

CONTACTHeidi S Hartman, MD
hl2738@cumc.columbia.edu212-305-3068
CONTACTMichelle Castillo, BS
mc5067@cumc.columbia.edu212-305-9161
PRINCIPAL_INVESTIGATORPierre A Elias, MD

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026