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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07398950

Acronym

TRACE-AI Yale

Enrollment

150

Registered

2026-02-10

Start date

2026-07-31

Completion date

2027-06-01

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIAGNOSTIC_TESTATTR-CM AI-ECG and AI-Echo Model

AI-based sequential screening approach for ATTR-CM

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Performance of the sequential screening approach	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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRohan Khera, MD, MS

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026