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.
Aged 18 years or above
Has new or worsening of heart failure symptoms
Elevated heart failure blood markers (N-terminal prohormone of brain natriuretic peptide, "NTproBNP") within 3 months from enrolment or by point-of-care blood test, to ensure that the patient's symptoms are cardiac origin
Provision of written informed consent
Known severe valvular heart disease
Prior prosthetic valve implantation
Previously known or suspected >=severe tricuspid regurgitation, >=moderate aortic regurgitation, >=moderate mitral stenosis or pericardial disease during detected during image acquisition
Insufficient image quality for proper analysis determined by the scanning sonographer (estimated to be 15% of all echocardiograms screened)
Parallel
Tailored AI echocardiogram analysis and reporting system
Diagnostic testIn 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.
Rate of complete agreement in LVEF assessments
To assess the rate of agreement in LVEF assessments between AI and sonographers with final adjudication by experienced cardiologist
Rate of complete agreement in assessments of AS severity
To assess the rate of agreement in severity of AS assessments between AI and sonographers with final adjudication by experienced cardiologist
Rate of complete agreement in assessment of MR severity
To assess the rate of agreement in severity of MR assessments between AI and sonographers with final adjudication by experienced cardiologist
Time used for image acquisition echocardiogram process
Compare the time used by AI system and sonographers for image acquisition.
Time used forreport drafting echocardiogram process
Compare the time used by AI system and sonographers for report drafting.
Time used for report endorsement
Compare the time used by AI system and sonographers for report endorsement.
Time used for total echocardiogram process
Compare the time used by AI system and sonographers for total echocardiogram process.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
