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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

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Conditions

ATTR Amyloidosis With CardiomyopathyHeart Failure

Locations

Yale New Haven Health System

New Haven, Connecticut 06519

United States