Clinical Trial

Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Study acronym: TRACE-AI Yale
Recruiting
View on ClinicalTrials.gov →
Summary
The TRACE-AI Diagnostic Study will evaluate the performance of artificial intelligence (AI) models applied to electrocardiograms (AI-ECG) and echocardiograms (AI-Echo) to identify transthyretin amyloid cardiomyopathy (ATTR-CM) in adults with heart failure. Model performance will be validated through comparison with technetium-99m pyrophosphate (PYP) imaging results.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-29
notable Primary completion pushed: 2026-12 -> 2027-06 2026-07-17
minor Completion pushed: 2026-12 -> 2027-06 2026-07-17
Trial Details
NCT Number NCT07398950
Lead Sponsor Yale University
Collaborators: Bridgebio Pharma, Inc
Conditions ATTR Amyloidosis With Cardiomyopathy, Heart Failure
Enrollment 150 participants
Start Date 2026-07-31
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-28