DELINEATE-Prospective

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-15

Study Completion Date

2028-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention Group

Studies meeting the following criteria will undergo adjudication by an expert panel: Moderate, moderate-severe, or severe mitral, aortic, or tricuspid regurgitation by physician or AI model assessment.

Discrepancy between physician and AI interpretations, where AI-assessed severity is greater than the physician-assessed severity (i.e. indicates that more valvular regurgitation is present)

No interventions assigned to this group

Control Group

A stratified random sample of cases will be selected to match the distribution of AI-flagged cases by physician-assessed valvular regurgitation severity and will undergo the same expert panel adjudication.

No interventions assigned to this group

Eligibility Criteria

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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