The Transthyretin Amyloid Cardiomyopathy Early Detection With Artificial Intelligence (TRACE-AI) Network Study
Trial ID: NCT07062848
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-01-24
Completion date: 2027-01
Sponsor: Yale University
Collaborators: Bridgebio Pharma, Inc
Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy
Interventions: AI Toolkit for ATTR-CM Diagnosis
Locations: University of California - San Francisco (UCSF) Health; Yale New Haven Health System; Henry Ford Health; Mount Sinai; Duke Health; Providence Health; Medical University of South Carolina (MUSC) Health; UT Southwestern Medical Center; Houstin Methodist; University of Virginia School of Medicine; University of Washington Medicine
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 1500000
Age range: 50 Years - 95 Years
Sex: ALL

Summary:
This is a multi-center, observational study with the overall objective to examine the scale of under-diagnosis for transthyretin amyloid cardiomyopathy (ATTR-CM) across a broad range of diverse health systems in the US using a fully federated deployment of an artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE).

Eligibility criteria:
Broad inclusion and exclusion criteria across all 3 objectives:

Inclusion Criteria:

* Age 50-95
* At least one retrievable ECG and/or 2D echo file (DICOM or equivalent video file) from EHR.

Exclusion Criteria:

* Unavailable key demographics (age, gender, race, ethnicity)
* Individuals who have opted out of research studies

Objective-specific inclusion and exclusion criteria:

Primary Objective:

Additional exclusion criteria:

* For subgroup analyses: when evaluating the prevalence of probable ATTR-CM status across demographic groups, we will exclude those with missing baseline demographic information (age, sex, race, geographic region).

Secondary Objective 1:

Additional inclusion criteria:

* 'Cases': ATTR-CM diagnosis defined by ICD-10 codes (Table 1) OR abnormal bone scintigraphy testing consistent with ATTR-CM OR treatment with an approved transthyretin stabilizer or other ATTR-CM-specific therapy
* 'Controls': any individuals not meeting the case definition. In these participants, we will consider all eligible ECG, POCUS, or TTE studies performed up to 12 months before diagnosis (first date of ICD code appearance, abnormal bone scintigraphy or treatment onset, whichever happened first) and any time after. 'Controls' will be drawn from ECGs, POCUS, or TTE studies performed in individuals not meeting the 'case' criteria above, including individuals who have never undergone dedicating testing or those who underwent e.g., bone scintigraphy, but with negative (or equivocal) findings.

Secondary Objective 2:

Additional inclusion criteria:

* Having at least two years of follow-up time between the index test (ECG, POCUS, or TTE) and the date of analysis.
* Having at least one healthcare encounter every two years across care settings from their first entry into the cohort through death or end of the follow-up period.

Outcomes:
To describe the prevalence of probable AI-defined ATTR-CM in defined cohorts of individuals who have undergone standard cardiovascular investigations across a diverse network of US-based health care delivery systems