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Enrolling By Invitation
NCT07398950
Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Conditions: ATTR Amyloidosis With Cardiomyopathy, Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Yale University
Location: Yale New Haven Health System New Haven Connecticut
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
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.
Source: ClinicalTrials.gov (NCT07398950). StuddyBuddy aggregates publicly available trial information.