Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Purpose
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.
Conditions
- ATTR Amyloidosis With Cardiomyopathy
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Yale New Haven Health System
New Haven, Connecticut 06519
New Haven, Connecticut 06519
More Details
- Status
- Recruiting
- Sponsor
- Yale University