Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
NCT07398950 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2026-02-10
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.
Conditions
- ATTR Amyloidosis With Cardiomyopathy
- Heart Failure
Interventions
- DIAGNOSTIC_TEST
-
ATTR-CM AI-ECG and AI-Echo Model
AI-based sequential screening approach for ATTR-CM
Sponsors & Collaborators
-
Bridgebio Pharma, Inc
collaborator UNKNOWN -
Yale University
lead OTHER
Principal Investigators
-
Rohan Khera, MD, MS · Yale University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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