ClinicalTrials.gov record NCT07398950

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study evaluates AI models applied to ECGs and echocardiograms to detect transthyretin (ATTR) cardiomyopathy in adults with heart failure. Sequential AI-ECG and AI-Echo screening results will be compared with confirmatory technetium-99m pyrophosphate (PYP) imaging and clinical testing. The primary measurement is the positive predictive value of the AI-based sequential screening.

What it is studying. Whether AI-based analyses of ECG and echocardiogram data can identify transthyretin amyloid cardiomyopathy when compared with confirmatory PYP imaging and clinical testing. The study evaluates a sequential screening approach using AI-ECG followed by AI-Echo.

What the researchers hope to learn. To validate the diagnostic performance of a sequential AI-ECG and AI-Echo screening approach for ATTR-CM by comparing results against confirmatory PYP imaging and clinical testing, and to measure the screening approach's positive predictive value.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test: ATTR-CM AI-ECG and AI-Echo Model

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would give informed consent and the study will use your prior AI-ECG and AI-Echo screening results from Phase I (within the past 36 months). At a baseline visit you will undergo a technetium-99m pyrophosphate (PYP) scan and any additional clinical testing needed to confirm or rule out transthyretin cardiac amyloidosis. The study team will compare the AI screening results with the PYP and clinical test results to evaluate the screening approach. The registry record does not list other procedures or follow-up details.

How the study is structured. A prospective observational cohort study. Participants previously screened in the Phase I TRACE-AI work will have a baseline visit with confirmatory technetium-99m pyrophosphate (PYP) imaging and clinical testing. Researchers will compare the AI screening results with imaging and clinical findings to assess diagnostic performance.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jul 31, 2026 (estimated)
Primary completion: June 2027 (estimated)
Study completion: June 2027 (estimated)
Target enrollment: 150 participants (estimated)
Last updated on registry: Aug 18, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Yale University
Collaborators: Bridgebio Pharma, Inc

Participating sites (1)

Yale New Haven Health System
New Haven, Connecticut, 06519 · United States

Terms used on this page · explanations by MedicalUpdates.ai

ECG: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Phase I: An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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