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Testing AI on Heart Tracings to Find Amyloid Heart Disease in Heart Failure

Tests whether AI reading heart tests can spot ATTR-CM in adults with heart failure.

Plain-language title generated from the registry record
Registry title: Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Key facts

Where
New Haven, United StatesSee the site

Where in United States

  • Yale-New Haven Health SystemNew Haven, United StatesNo longer taking part

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Trial details

Who runs it
Yale University
Trial code
NCT07398950
Record updated
18 August 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Patients with cardiac amyloid diagnostic test in the past 36 months; Patients with hypertrophic cardiomyopathy or end-stage renal disease; Patients who have opted out of research studies; 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.

ClinicalTrials.gov NCT07398950