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Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure
Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Summary
This is a non-inferiority, three-year, multicenter, double-blinded randomized controlled study of an AI versus experienced sonographer echocardiogram analysis in HF patients. Consecutive patients presented for echocardiogram examination with new or worsening HF symptom and positive HF blood markers will be recruited. A target of 514 patients will be randomized 1:1 to receive either AI or sonographer echocardiogram analysis. The primary endpoint of diagnostic accuracy is the complete agreement of disease grading with an experienced cardiologist (American Society of Echocardiography level III) using a standardized grading chart. Important secondary endpoints include the time used for echocardiogram report drafting and report endorsement, 6-month heart failure symptom and hospitalization, and the cost-effectiveness of AI to increase echocardiogram service. Clinical, biochemical and echocardiographic predictors of worsening of heart failure and hospitalization will be identified.
Official title: Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
514
Start Date
2025-07-01
Completion Date
2028-12-03
Last Updated
2025-06-15
Healthy Volunteers
No
Conditions
Interventions
Tailored AI echocardiogram analysis and reporting system
In the AI analysis and reporting pathway, sonographers only need to acquire the echocardiogram images, then the AI algorithm will complete the analysis and report drafting for final endorsement by experienced cardiologists. To ensure blinding of group assignment to the endorsing experienced cardiologists, measurement format and reporting phrases and interface used by AI and sonographers will be standardized.
Locations (1)
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong