Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ATTR-CM AI-ECG and AI-Echo Model
Treatment groups
No treatment groups listed
Sponsors and collaborators
Yale University
Lead sponsor
Bridgebio Pharma, Inc
Collaborator
Source ClinicalTrials.gov