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| Name | Class |
|---|---|
| Bridgebio Pharma, Inc | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTR-CM AI-ECG and AI-Echo Model | Diagnostic Test | AI-based sequential screening approach for ATTR-CM |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment through completion of PYP scan at baseline study visit |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rohan Khera, MD, MS | Contact | 203-764-5885 | rohan.khera@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rohan Khera, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Health System | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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