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Enrolling by invitation

NCT Number: NCT07398950

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

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.

Enrolling by invitation

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Key information

Conditions

ATTR Amyloidosis With Cardiomyopathy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Health System

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

ATTR-CM AI-ECG and AI-Echo Model

Diagnostic Test

AI-based sequential screening approach for ATTR-CM

Primary outcomes

  1. Performance of the sequential screening approach

    Time frame: From enrollment through completion of PYP scan at baseline study visit

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Bridgebio Pharma, Inc

Registry information

Official study title

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

Acronym: TRACE-AI Yale

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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