Summary

Eligibility
for people ages 50-95 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

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).

Official Title

The Transthyretin Amyloid Cardiomyopathy Early Detection With Artificial Intelligence (TRACE-AI) Network Study

Keywords

Transthyretin (TTR) Amyloid Cardiomyopathy, artificial intelligence, AI-ECG, AI-Echo, cardiac amyloidosis, transthyretin amyloid cardiomyopathy, Cardiomyopathies, Amyloidosis, AI Toolkit for ATTR-CM Diagnosis

Eligibility

For people ages 50-95

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.

Locations

  • UCSF (UCSF) Health
    San Francisco California 94143 United States
  • Providence Health
    Tigard Oregon 97224 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
ID
NCT07062848
Study Type
Observational
Participants
Expecting 1500000 study participants
Last Updated