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Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure

NCT07021599 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-07-03
Completion
2028-12-03

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021599 on ClinicalTrials.gov