Heart Failure / ATTR-CM AI-ECG and AI-Echo Model / ATTR Amyloidosis With Cardiomyopathy · Observational Study

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

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record describing a planned prospective observational study to validate AI models applied to ECG and echocardiography for detection of transthyretin amyloid cardiomyopathy in adults with heart failure. No results are posted in this registry record; the study is actively enrolling.

What was studied

Observational. ATTR Amyloidosis With Cardiomyopathy, Heart Failure; age from 18 Years. Intervention: ATTR-CM AI-ECG and AI-Echo Model. Compared with: Technetium-99m pyrophosphate (PYP) imaging. n = 150. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned observational diagnostic study with no results yet reported; it describes the design and enrollment target only.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Performance of the sequential screening approach (assessed at From enrollment through completion of PYP scan at baseline study visit)

DesignObservational

PopulationATTR Amyloidosis With Cardiomyopathy, Heart Failure; age from 18 Years

Sample size150

InterventionATTR-CM AI-ECG and AI-Echo Model

ComparatorTechnetium-99m pyrophosphate (PYP) imaging

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment150

Primary outcome measurePerformance of the sequential screening approach

Validation reference standardTechnetium-99m pyrophosphate (PYP) imaging

Caveats

This is a registry record only; no results, effect sizes, or outcomes are reported.
Study sponsor and recruitment sites not fully detailed in this record.
Primary outcome is diagnostic performance; no clinical outcome data will result from this study.
Blinding, enrollment criteria, and statistical analysis plan not described in this registry excerpt.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design with prospective enrollment and diagnostic validation against imaging.

Directness

strong

Directly evaluates AI diagnostic performance against PYP imaging gold standard.

Consistency

insufficient

Registry record; no results posted; consistency cannot be assessed.

Risk of bias

insufficient

Study protocol not yet published; blinding and conduct details not described.

Sample adequacy

insufficient

Planned enrollment 150; no power calculation or statistical plan reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07398950). This is a study registration, not published results. Lead sponsor: Yale University. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: ATTR Amyloidosis With Cardiomyopathy, Heart Failure. Interventions: DIAGNOSTIC_TEST: ATTR-CM AI-ECG and AI-Echo Model. Primary outcome measures: Performance of the sequential screening approach , From enrollment through completion of PYP scan at baseline study visit. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Heart FailureYale UniversityATTR-CM AI-ECG and AI-Echo ModelNCT07398950ATTR Amyloidosis With Cardiomyopathy