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

Recruiting now

Conditions studied: ATTR Amyloidosis With Cardiomyopathy, Heart Failure

In brief

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.

Key facts

Study ID

NCT07398950

Run by

Yale University

People needed

150

Starts

2026-07-31

Expected to finish

2027-06-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Yale New Haven Health System — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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