Actively Recruiting
Artificial Intelligence in Aortic Regurgitation: A Multicenter Randomised Controlled Trial
Led by Chinese University of Hong Kong · Updated on 2026-03-20
540
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
S
Semmelweis University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an artificial intelligence (AI) tool designed to automatically detect and measure aortic regurgitation (AR). This tool aims to improve diagnosis by reducing variability and the need for specialized expertise in interpreting echocardiograms. The study compares the AI system with manual diagnostic methods across multiple centers in a randomized controlled trial, seeking to enhance accuracy, consistency, and accessibility of AR diagnosis, especially in resource-limited settings. Participants will be divided into two groups: one group will have AR severity assessed using the AI tool that analyzes key echocardiographic parameters such as Effective Regurgitant Orifice Area (EROA), Vena Contracta (VC), Proximal Isovelocity Surface Area (PISA), jet width, and Regurgitant Volume (RegVol), along with timing of assessments. The other group will have AR severity measured manually by trained sonographers following standard protocols. Cardiologists blinded to patient details will review both AI-generated and manual results to make final diagnoses and treatment decisions. During the study, participant data will be collected from baseline through 20 months, including accuracy of AR severity differentiation, deviations in key echocardiographic measurements, and the time taken to complete assessments. Participants will be followed up at 6 and 12 months to monitor outcomes such as all-cause mortality and heart failure hospitalizations. This design allows researchers to evaluate the clinical utility of the AI tool compared to traditional methods over time.
CONDITIONS
Brief Title
Artificial Intelligence in Aortic Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of aortic regurgitation by transthoracic echocardiography (TTE) and Doppler imaging following guidelines
- Age 18 years or older
- Adequate acoustic window for quantifying aortic regurgitation
You will not qualify if you...
- History of cardiac transplant or having implanted cardiac devices
- Poor image quality for assessment
- Pregnancy or currently breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessment
Participants undergo aortic regurgitation assessment using either an AI-assisted tool or manual measurements performed by trained sonographers.
1 visit (in-person)
Duration - Up to 12 months
Participants are followed up to monitor clinical outcomes including 1-year all-cause mortality and heart failure hospitalizations.
2 visits at 6 and 12 months
Trial Site Locations
Total: 1 location
1
Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong, New Territories, Hong Kong, Sha Tin
Actively Recruiting
Research Team
X
Xueting Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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