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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07398950
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATTR-CM AI-ECG and AI-Echo Model — DIAGNOSTIC_TEST
    AI-based sequential screening approach for ATTR-CM

Study Details

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.

Key Dates

First listed
Feb 10, 2026
Start date
Jul 31, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Health SystemNew HavenConnecticut06519-

Find similar trials in New Haven, CT

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By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Yale New Haven Health System· New Haven, CT

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