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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-24

Study Completion Date

2027-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Transthyretin (TTR) Amyloid Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AI Toolkit for ATTR-CM Diagnosis

An artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

* '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:

* 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.

Exclusion Criteria

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

Primary Objective:

* 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:

Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No