Transthyretin (TTR) Amyloid CardiomyopathyTRACE NetworkNCT07062848
An Observational Study Using Artificial Intelligence (AI) Algorithms on Electrocardiography (ECG), Point-of-care Ultrasound (POCUS), and Transthoracic Echocardiophy (TTE) to Estimate the Under-diagnosis of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Across a Diverse Range of US Health Systems.
An observational study of Transthyretin (TTR) Amyloid Cardiomyopathy, run by Yale University at 12 sites in United States.
Trial summary
This is a multi-center, observational study with the overall objective to examine the scale of under-diagnosis for transthyretin amyloid cardiomyopathy (ATTR-CM) across a broad range of diverse health systems in the US using a fully federated deployment of an artificial intelligence (AI) toolkit of algorithms that… Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Transthyretin (TTR) Amyloid Cardiomyopathy
- What is being tested?
- AI Toolkit for ATTR-CM Diagnosis
- How many people
- 1,500,000 participants
- Where
- 12 sitesUnited States
- Study dates
- 24 Jan 2025to Jan 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include US adults ages 50-95 with at least one retrievable ECG and/or 2D echo file from HER.
Who may be able to join
- Age 50-95
- At least one retrievable ECG and/or 2D echo file (DICOM or equivalent video file) from EHR.
Who cannot join
- Unavailable key demographics (age, gender, race, ethnicity)
- Individuals who have opted out of research studies
- Objective-specific inclusion and exclusion criteria:
- Primary Objective:
- Additional exclusion criteria:
- For subgroup analyses: when evaluating the prevalence of probable ATTR-CM status across demographic groups, we will exclude those with missing baseline demographic information (age, sex, race, geographic region).
Show all 14Show fewer
- Secondary Objective 1:
- Additional inclusion criteria:
- 'Cases': ATTR-CM diagnosis defined by ICD-10 codes (Table 1) OR abnormal bone scintigraphy testing consistent with ATTR-CM OR treatment with an approved transthyretin stabilizer or other ATTR-CM-specific therapy
- 'Controls': any individuals not meeting the case definition. In these participants, we will consider all eligible ECG, POCUS, or TTE studies performed up to 12 months before diagnosis (first date of ICD code appearance, abnormal bone scintigraphy or treatment onset, whichever happened first) and any time after. 'Controls' will be drawn from ECGs, POCUS, or TTE studies performed in individuals not meeting the 'case' criteria above, including individuals who have never undergone dedicating testing or those who underwent e.g., bone scintigraphy, but with negative (or equivocal) findings.
- Secondary Objective 2:
- Additional inclusion criteria:
- Having at least two years of follow-up time between the index test (ECG, POCUS, or TTE) and the date of analysis.
- Having at least one healthcare encounter every two years across care settings from their first entry into the cohort through death or end of the follow-up period.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Medical University of South Carolina (MUSC) Health
Charleston, South Carolina, 29425
University of Virginia School of Medicine
Charlottesville, Virginia, 22903
The University of Chicago
Chicago, Illinois, 60637
UT Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health
Detroit, Michigan, 48202
Houstin Methodist
Houston, Texas, 77030
Yale New Haven Health System
New Haven, Connecticut, 06519
Mount Sinai
New York, New York, 10029
University of California - San Francisco (UCSF) Health
San Francisco, California, 94143
University of Washington Medicine
Seattle, Washington, 98195
Montefiore
The Bronx, New York, 10467
Providence Health
Tigard, Oregon, 97224
About this study
Official title: The Transthyretin Amyloid Cardiomyopathy Early Detection With Artificial Intelligence (TRACE-AI) Network Study
This is a multi-center, observational study with the overall objective to examine the scale of under-diagnosis for transthyretin amyloid cardiomyopathy (ATTR-CM) across a broad range of diverse health systems in the US using a fully federated deployment of an artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE).
- Being tested
- AI Toolkit for ATTR-CM Diagnosis
- Keywords
- artificial intelligence, AI-ECG, AI-Echo, cardiac amyloidosis, transthyretin amyloid cardiomyopathy
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Toolkit for ATTR-CM DiagnosisDiagnostic test
An artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE)
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the prevalence of probable AI-defined ATTR-CM in defined cohorts of individuals who have undergone standard cardiovascular investigations across a diverse network of US-based health care delivery systems
Measured: At enrollment
Secondary outcomes (2)
Validate the diagnostic performance of AI-enabled ECG, POCUS, and TTE algorithms for ATTR-CM
Measured: At enrollment
To examine the association between the AI-defined probability of ATTR-CM and the incidence of adverse cardiovascular events
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start24 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin (TTR) Amyloid 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
- Retrospective
- Enrolment
- 1,500,000 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
- NCT07062848
- Sponsor's protocol ID
- 2000039184
- Acronym
- TRACE Network
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transthyretin Amyloid Cardiomyopathy Early Detection With Artificial Intelligence (TRACE-AI) Network Study
- ClinicalTrials.gov ID
- NCT07062848
- Acronym / sponsor ID
- TRACE Network / 2000039184
- Keywords
- artificial intelligence, AI-ECG, AI-Echo, cardiac amyloidosis, transthyretin amyloid cardiomyopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500,000 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bridgebio Pharma, Inc
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Jul 2025 (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.
This is a multi-center, observational study with the overall objective to examine the scale of under-diagnosis for transthyretin amyloid cardiomyopathy (ATTR-CM) across a broad range of diverse health systems in the US using a fully federated deployment of an artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include US adults ages 50-95 with at least one retrievable ECG and/or 2D echo file from HER.
Key inclusion criteria (2 listed)
- Age 50-95
- At least one retrievable ECG and/or 2D echo file (DICOM or equivalent video file) from EHR.
Key exclusion criteria (14 listed)
- Unavailable key demographics (age, gender, race, ethnicity)
- Individuals who have opted out of research studies
- For subgroup analyses: when evaluating the prevalence of probable ATTR-CM status across demographic groups, we will exclude those with missing baseline demographic information (age, sex, race, geographic region).
- 'Cases': ATTR-CM diagnosis defined by ICD-10 codes (Table 1) OR abnormal bone scintigraphy testing consistent with ATTR-CM OR treatment with an approved transthyretin stabilizer or other ATTR-CM-specific therapy
- 'Controls': any individuals not meeting the case definition. In these participants, we will consider all eligible ECG, POCUS, or TTE studies performed up to 12 months before diagnosis (first date of ICD code appearance, abnormal bone scintigraphy or treatment onset, whichever happened first) and any time after. 'Controls' will be drawn from ECGs, POCUS, or TTE studies performed in individuals not meeting the 'case' criteria above, including individuals who have never undergone dedicating testing or those who underwent e.g., bone scintigraphy, but with negative (or equivocal) findings.
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 |
|---|---|---|
| AI Toolkit for ATTR-CM DiagnosisAn artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE) | Diagnostic test | – |
Primary outcome
To describe the prevalence of probable AI-defined ATTR-CM in defined cohorts of individuals who have undergone standard cardiovascular investigations across a diverse network of US-based health care delivery systems
Time frame: At enrollment
2 secondary outcomes
Validate the diagnostic performance of AI-enabled ECG, POCUS, and TTE algorithms for ATTR-CM
Time frame: At enrollment
To examine the association between the AI-defined probability of ATTR-CM and the incidence of adverse cardiovascular events
Time frame: At enrollment
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 29 Jul 2026.
Related trials for Transthyretin (TTR) Amyloid Cardiomyopathy
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Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis
Transthyretin (TTR) Amyloid Cardiomyopathy, Cardiac Amyloidosis
Not yet recruitingPhase 3
To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)
Amyloidosis in Transthyretin (TTR), Amyloidosis, Familial
RecruitingObservational study
Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
Transthyretin (TTR) Amyloid Cardiomyopathy
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. This study is not recruiting at the moment.
Rohan Khera, MD, MS principal investigator
Yale University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin (TTR) Amyloid Cardiomyopathy, run by Yale University at 12 sites 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 2 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
To describe the prevalence of probable AI-defined ATTR-CM in defined cohorts of individuals who have undergone standard cardiovascular investigations across a diverse network of US-based health care delivery systems (time frame: At enrollment). 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 29 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.