DELINEATE-Prospective
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Deep Learning for Echo Analysis, Tracking, and Evaluation Prospective Evaluation (DELINEATE-Prospective)
Overview
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.
Primary outcome measures
- Proportion of Clinically Meaningful Reclassification by Panel Review [Time frame: 18 months]
Secondary outcome measures (4)
- Proportion of Cases with AI-Based Reclassification Leading to a Change in Clinical Management [Time frame: 18 months]
- Proportion of Cases with AI-Based Reclassification Leading to Referral to a Valve Specialist or Surgeon [Time frame: 18 months]
- Proportion of Cases with AI-Based Reclassification Leading to a Change in Frequency of Follow-Up Echocardiography [Time frame: 18 months]
- Proportion of Cases with AI-Based Reclassification Leading to Referral for Further Testing (TEE or Cardiac MRI) [Time frame: 18 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT07197736 · AAAU9603