Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

NCT07398950 | Not Yet Recruiting

• 1 other identifier: 2000039677
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The TRACE-AI Diagnostic Study will evaluate the performance of artificial intelligence (AI) models applied to electrocardiograms (AI-ECG) and echocardiograms (AI-Echo) to identify transthyretin amyloid cardiomyopathy (ATTR-CM) in adults with heart failure. Model performance will be validated through comparison with technetium-99m pyrophosphate (PYP) imaging results.

Conditions

ATTR Amyloidosis With Cardiomyopathy; Heart Failure

Keywords

Transthyretin Amyloid Cardiomyopathy (ATTR-CM); Artificial Intelligence Screening; AI-ECG; AI-Echo; Electrocardiogram; Technetium-99m Pyrophosphate (Tc99m-PYP) Scintigraphy; Machine Learning in Cardiology; Validation of AI Diagnostic Tools; Cardiomyopathy Screening; Early Detection of Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Performance of the sequential screening approach

  Measured by the positive predictive value (PPV) of the test for ATTR-CM, based on confirmatory imaging and clinical testing

  From enrollment through completion of PYP scan at baseline study visit

Interventions

ATTR-CM AI-ECG and AI-Echo Model DIAGNOSTIC_TEST

AI-based sequential screening approach for ATTR-CM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants from the YNHHS who were identified in Phase I of the TRACE-AI study. Eligible individuals must have a confirmed diagnosis of HFpEF or HFmrEF, 75 with a positive AI-based screening result from both AI-ECG and AI-Echo and 75 with a negative AI-based screen, and no prior diagnostic work-up for cardiac amyloidosis.

You may qualify if:

• Patients 18 years or older with at least one of each component cardiovascular diagnosis testing (ECG and Echo) in the YNHHS.
• Patients with a diagnosis of HFpEF or HFmrEF
• Participant from Phase I TRACE-AI Study with AI-ECG and AI-Echo screen in the preceding 36 months

You may not qualify if:

• Patients who have opted out of research studies
• Patients with cardiac amyloid diagnostic test in the past 36 months
• Patients with hypertrophic cardiomyopathy or end-stage renal disease
• Pregnant women
• Patients unable or unwilling to provide informed consent
• Non-English speakers and cognitively impaired individuals who are unable to comprehend the consent and the on-screen instructions on the application, which are in English.

Sponsors & Collaborators

• Yale University: lead
• Bridgebio Pharma, Inc: collaborator

Study Sites (1)

Yale New Haven Health System

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rohan Khera, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohan Khera, MD, MS

CONTACT

203-764-5885; rohan.khera@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)