An Observational Study Using Artificial Intelligence (AI) Algorithms on Electrocardiography (ECG), Point-of-care Ultrasound (POCUS), and Transthoracic Echocardiophy (TTE) to Estimate the Under-diagnosis of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Across a Diverse Range of US Health Systems.

Running, not enrolling

Conditions studied: Transthyretin (TTR) Amyloid Cardiomyopathy

In brief

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).

Key facts

Study ID: NCT07062848
Run by: Yale University
People needed: 1500000
Starts: 2025-01-24
Expected to finish: 2027-01-01
Last updated by the study team: 2026-07-29

Who can join

Age: 50 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

University of California - San Francisco (UCSF) Health — San Francisco, California, United States
Yale New Haven Health System — New Haven, Connecticut, United States
The University of Chicago — Chicago, Illinois, United States
Henry Ford Health — Detroit, Michigan, United States
Mount Sinai — New York, New York, United States
Montefiore — The Bronx, New York, United States
Providence Health — Tigard, Oregon, United States
Medical University of South Carolina (MUSC) Health — Charleston, South Carolina, United States
UT Southwestern Medical Center — Dallas, Texas, United States
Houstin Methodist — Houston, Texas, United States
University of Virginia School of Medicine — Charlottesville, Virginia, United States
University of Washington Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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