An Observational Study Using Artificial Intelligence (AI)... | NCT07062848

Studies
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.

NCT07062848

Sponsor

Yale University

Status

Active, not recruiting

Last Update Posted

Jul 14, 2025Actual

Enrollment

1,500,000Estimated

Phase

Not provided

Conditions

Transthyretin (TTR) Amyloid Cardiomyopathy

Interventions

AI Toolkit for ATTR-CM Diagnosis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 24, 2025Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Jul 3, 2025

First Submission Date that Met QC Criteria

Jul 3, 2025

First Posted Date

Jul 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2025

Last Update Posted Date

Jul 14, 2025Actual

Name	Class
Bridgebio Pharma, Inc	UNKNOWN

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
AI Toolkit for ATTR-CM Diagnosis	Diagnostic Test	An artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		At enrollment

Secondary Outcomes

Measure	Description	Time Frame
Validate the diagnostic performance of AI-enabled ECG, POCUS, and TTE algorithms for ATTR-CM		At enrollment
To examine the association between the AI-defined probability of ATTR-CM and the incidence of adverse cardiovascular events		At enrollment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

The study will include US adults ages 50-95 with at least one retrievable ECG and/or 2D echo file from HER.

Sampling Method

Non-Probability Sample

ID	Term
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D009422	Nervous System Diseases
D017772	Amyloid Neuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D028226	Amyloidosis, Familial
D008661	Metabolism, Inborn Errors
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D000686	Amyloidosis
D057165	Proteostasis Deficiencies