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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will include participants from the YNHHS who were identified in Phase I of the TRACE-AI study. Eligible individuals must have a confirmed diagnosis of HFpEF or HFmrEF, 75 with a positive AI-based screening result from both AI-ECG and AI-Echo and 75 with a negative AI-based screen, and no prior diagnostic work-up for cardiac amyloidosis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ATTR-CM AI-ECG and AI-Echo Model
Diagnostic testAI-based sequential screening approach for ATTR-CM
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Performance of the sequential screening approach
Measured by the positive predictive value (PPV) of the test for ATTR-CM, based on confirmatory imaging and clinical testing
Time frame
From enrollment through completion of PYP scan at baseline study visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Bridgebio Pharma, Inc
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: