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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Study details
    ATTR Amyloidosis With Cardiomyopathy
    Heart Failure

NCT07398950

Yale University

1 August 2026

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