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

RECRUITINGSponsored by Yale University
Actively Recruiting
SponsorYale University
Started2026-07-31
Est. completion2027-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

ATTR Amyloidosis With CardiomyopathyHeart DiseaseHeart Failure

Locations1 site

Yale New Haven Health System
New Haven, Connecticut, 06519
Rohan Khera, MD, MS203-764-5585rohan.khera@yale.edu

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