Actively Recruiting

Age: 18Years +
All Genders
NCT07197736

DELINEATE-Prospective

Led by Columbia University · Updated on 2026-04-16

50

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

DELINEATE-Prospective

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

H

Heidi S Hartman, MD

CONTACT

M

Michelle Castillo, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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