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Recruiting NCT07486271

Artificial Intelligence in Aortic Regurgitation

No phase Interventional Aortic Regurgitation Disease

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
The protocol lists: AI-Assisted Group, Manual measurement group.
Who it may be relevant to
Registry conditions: Aortic Regurgitation 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
Hong Kong
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

Artificial Intelligence in Aortic Regurgitation: A Multicenter Randomised Controlled Trial

Overview

This research project aims to develop and validate a tool that uses artificial intelligence (AI) to automatically detect and quantify aortic regurgitation (AR). The clinical efficacy of this tool will be established by comparing it to manual diagnostic methods in a multicenter randomized controlled trial. By leveraging deep learning (DL) techniques, the AI system will automate aortic regurgitation (AR) detection, measurement, and diagnosis, addressing challenges like variability in echocardiographic interpretations and the need for specialized expertise. It will integrate multiple echocardiographic parameters to provide accurate, standardized, and efficient AR diagnoses, reducing human error and improving consistency. This tool will enhance diagnostic precision and accessibility, improving clinical outcomes and extending advanced diagnostic capabilities to a broader range of healthcare environments, including resource-limited settings.

Interventions

  • Diagnostic test AI-Assisted Group
    Participants in this group will undergo aortic regurgitation assessment using an advanced artificial intelligence tool.
  • Other Manual measurement group
    Participants in this group will receive a traditional diagnostic assessment for aortic regurgitation, performed by trained sonographers following standard protocols.

Primary outcome measures

  • Study Outcomes [Time frame: This will be recorded from baseline to study completion (20 months)]
Secondary outcome measures (8)
  • Comparing Accuracy in Differentiating AR Severity Levels [Time frame: This will be recorded from baseline to study completion (20 months)]
  • Assessing deviations in Effective Regurgitant Orifice Area (EROA) [Time frame: This will be recorded from baseline to study completion (20 months)]
  • Assessing deviations in Vena Contracta (VC) [Time frame: This will be recorded from baseline to study completion (20 months)]
  • Assessing deviations in Proximal Isovelocity Surface Area (PISA) [Time frame: This will be recorded from baseline to study completion (20 months)]
  • Assessing deviations in jet width [Time frame: This will be recorded from baseline to study completion (20 months)]
  • Assessing deviations in Regurgitant Volume (RegVol) [Time frame: This will be recorded from baseline to study completion (20 months)]
  • Comparing Assessment Completion Time [Time frame: The time taken for each method to reach a diagnosis will be recorded from baseline to study completion (20 months)]
  • Tracking 1-Year Outcomes [Time frame: Participants will be followed up at 6 and 12 months to monitor outcomes, including 1-year all-cause mortality and HFH.]

Eligibility criteria

Inclusion criteria

  • Confirmed AR diagnosis via TTE and Doppler imaging per guidelines.
  • Age ≥ 18 years.
  • Adequate acoustic window for AR quantification.

Exclusion criteria

  • Prior cardiac transplant or implanted cardiac devices.
  • Poor image quality.
  • Pregnancy or lactation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Hong Kong · 1 center
  • Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The C — Hong Kong

Identifiers

NCT: NCT07486271 · 2024.689-T

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗