ATTR Amyloidosis With CardiomyopathyTRACE-AI YaleNCT07398950
Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
An observational study of ATTR Amyloidosis With Cardiomyopathy and Heart Failure, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATTR Amyloidosis With Cardiomyopathy, Heart Failure
- What is being tested?
- ATTR-CM AI-ECG and AI-Echo Model
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants from the YNHHS who were identified in Phase I of the TRACE-AI study. Eligible individuals must have a confirmed diagnosis of HFpEF or HFmrEF, 75 with a positive AI-based screening result from both AI-ECG and AI-Echo and 75 with a negative AI-based screen, and no prior diagnostic work-up for cardiac amyloidosis.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale New Haven Health System
New Haven, Connecticut, 06519
About this study
Official title: Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM): TRACE-AI Prospective Study
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.
- Being tested
- ATTR-CM AI-ECG and AI-Echo Model
- 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
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTR-CM AI-ECG and AI-Echo ModelDiagnostic test
AI-based sequential screening approach for ATTR-CM
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the sequential screening approach
Measured by the positive predictive value (PPV) of the test for ATTR-CM, based on confirmatory imaging and clinical testing
Measured: From enrollment through completion of PYP scan at baseline study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start31 Jul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATTR Amyloidosis With CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Bridgebio Pharma, Inc
- Responsible party
- Sponsor
- Investigators
- Rohan Khera, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398950
- Sponsor's protocol ID
- 2000039677
- Acronym
- TRACE-AI Yale
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM): TRACE-AI Prospective Study
- ClinicalTrials.gov ID
- NCT07398950
- Acronym / sponsor ID
- TRACE-AI Yale / 2000039677
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bridgebio Pharma, Inc
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants from the YNHHS who were identified in Phase I of the TRACE-AI study. Eligible individuals must have a confirmed diagnosis of HFpEF or HFmrEF, 75 with a positive AI-based screening result from both AI-ECG and AI-Echo and 75 with a negative AI-based screen, and no prior diagnostic work-up for cardiac amyloidosis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATTR-CM AI-ECG and AI-Echo ModelAI-based sequential screening approach for ATTR-CM | Diagnostic test | – |
Primary outcome
Performance of the sequential screening approach
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rohan Khera, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ATTR Amyloidosis With Cardiomyopathy and Heart Failure, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the sequential screening approach (time frame: From enrollment through completion of PYP scan at baseline study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.