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Recruiting NCT07398950

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

— Observational ATTR Amyloidosis With Cardiomyopathy Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ATTR-CM AI-ECG and AI-Echo Model.
Who it may be relevant to
Registry conditions: ATTR Amyloidosis With Cardiomyopathy, Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test ATTR-CM AI-ECG and AI-Echo Model
    AI-based sequential screening approach for ATTR-CM

Primary outcome measures

  • Performance of the sequential screening approach [Time frame: From enrollment through completion of PYP scan at baseline study visit]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Yale New Haven Health System — New Haven

Identifiers

NCT: NCT07398950 · 2000039677

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗