NCT07398950Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 31 Jul 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Yale University
- Diseases
- Amyloidosis, Heart failure
- NCT number
- NCT07398950
What you commit to
- Study type: Observational
- Planned participants: 150
- From 31 Jul 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with cardiac amyloid diagnostic test in the past 36 months
- Patients with hypertrophic cardiomyopathy or end-stage renal disease
Other
- Patients who have opted out of research studies
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale-New Haven Health System Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.