NCT07398950Recruiting
Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Yale University
Start Date
7/31/2026
Completion Date
6/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Patients 18 years or older with at least one of each component cardiovascular diagnosis testing (ECG and Echo) in the YNHHS.
* Patients with a diagnosis of HFpEF or HFmrEF
* Participant from Phase I TRACE-AI Study with AI-ECG and AI-Echo screen in the preceding 36 months
Exclusion Criteria:
* Patients who have opted out of research studies
* Patients with cardiac amyloid diagnostic test in the past 36 months
* Patients with hypertrophic cardiomyopathy or end-stage renal disease
* Pregnant women
* Patients unable or unwilling to provide informed consent
* Non-English speakers and cognitively impaired individuals who are unable to comprehend the consent and the on-screen instructions on the application, which are in English.
Interventions
DIAGNOSTIC_TEST
ATTR-CM AI-ECG and AI-Echo Model
Conditions
ATTR Amyloidosis With CardiomyopathyHeart Failure
Locations
Yale New Haven Health System
New Haven, Connecticut 06519
United States