ClinicalTrials.gov record NCT07690436
Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM
A Multicenter Pilot Study to Investigate Ocular Involvement and the Potential of Ocular Imaging for Non-invasive Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
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 multicenter pilot observational study collects eye images from adults with confirmed ATTR-CM and from heart failure control participants. Imaging and related data are taken at a single time point to see if a machine-learning model can distinguish ATTR-CM from other heart failure. The study is observational and does not assign any treatments.
What it is studying. Whether retinal fundus imaging and optical coherence tomography (OCT) contain features that a machine-learning model can use to tell clinically confirmed transthyretin amyloid cardiomyopathy (ATTR-CM) cases apart from heart failure controls without ATTR-CM.
What the researchers hope to learn. Assess feasibility of using ocular imaging to detect ATTR-CM; identify image features the model learns that are indicative of ATTR pathology; preliminarily measure model performance (sensitivity, specificity, AUROC) and compare score distributions across subgroups.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This multicenter pilot study will enroll adult participants with a confirmed clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) and heart failure (HF) controls with documentation within the past 2 years that either excludes ATTR-CM or indicates a low probability of ATTR-CM. Ocular imaging and other study data will be collected to assess the feasibility of developing and preliminarily evaluating a machine learning model to discriminate ATTR-CM cases from HF controls without ATTR-CM.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Participant must be 18 years and older at the time of signing the informed consent form.
- Participants with either of the following:
- Positive ATTR-CM cases: Participants with a clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) with amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining, or DPD-Tc, PYP-Tc, or HMDP-Tc scintigraphy with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio.
- Control population: Participants with a clinical diagnosis of guideline-directed medical therapy-directed heart failure (HF) and either:
- a) Subgroup A: Definitively excluded ATTR-CM amyloidosis: negative cardiac or non-cardiac tissue biopsy for amyloid, or negative technetium scintigraphy within the past 2 years.
- b) Subgroup B: Low probability of ATTR-CM amyloidosis, not definitively excluded: absence of amyloid-suggestive features on echocardiography (ECHO), electrocardiography (ECG), or cardiac magnetic resonance imaging (MRI) within the past 2 years, with documented clinical assessment indicating HF etiology unlikely attributable to amyloidosis; no amyloid-specific testing (technetium scintigraphy or biopsy) performed.
- Participant or legally authorized representative (LAR) must sign the informed consent form.
Exclusion criteria
- Any known eye condition that may preclude clear imaging of the retina.
- Any known history of amyloid light-chain (AL) amyloidosis.
- Any ocular surgery that, in the opinion of the investigator, makes participation in the study undesirable.
- Any medical condition that, in the opinion of the investigator, makes participation in the study undesirable, for example, if the participant is critically unwell or requires ongoing emergency treatment.
- Involvement in the planning and/or conduct of the study.
- In the opinion of the investigator, the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrollment in the present study.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
A participant who does not complete the study within 90 days from enrollment will be discontinued from the study. A participant may be discontinued from the study at any time at the discretion of the investigator for behavioral or compliance reasons. A participant may withdraw from the study at any time at the participant's own request for any reason (or without providing any reason) without any implication on participant's rights.
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.
Participants will have a single study assessment visit within 90 days of signing consent that includes non-invasive ocular imaging (retinal fundus imaging and optical coherence tomography) and collection of other study data. Images and clinical information will be used to evaluate feasibility of a machine-learning model to distinguish ATTR‑CM from heart-failure controls. A participant who does not complete the study procedures within 90 days may be discontinued; participants may also be withdrawn by the investigator for behavioral/compliance reasons or may withdraw themselves at any time without affecting their rights.
How the study is structured. Observational, case-control, cross-sectional study. Adults with confirmed ATTR-CM are compared with heart failure control participants. Each person has ocular imaging and other study data collected once (within 90 days of consent). Data will be used to train and preliminarily evaluate a machine-learning model; no treatments are given by the study.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Transthyretin Amyloid Cardiomyopathy. Does it apply to my diagnosis?
- 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 listed sites are in Germany, Portugal, Spain, Sweden, 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
Important dates
- Study start
- Jul 8, 2026
- Primary completion
- Jun 18, 2027 (estimated)
- Study completion
- Jun 18, 2027 (estimated)
- Target enrollment
- 500 participants (estimated)
- Last updated on registry
- Aug 26, 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
- AstraZeneca
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- AstraZeneca Clinical Study Information Center 📞 1-877-240-9479 ✉ information.center@astrazeneca.com
Participating sites (20)
- Research SiteNot Yet Recruiting
Palo Alto, California, 94305 · United States
- Research SiteNot Yet Recruiting
Jacksonville, Florida, 32224 · United States
- Research SiteNot Yet Recruiting
Chicago, Illinois, 60611 · United States
- Research SiteNot Yet Recruiting
Boston, Massachusetts, 02114 · United States
- Research SiteNot Yet Recruiting
Portland, Oregon, 97239-3098 · United States
- Research SiteNot Yet Recruiting
Germantown, Tennessee, 38138 · United States
- Research SiteNot Yet Recruiting
Berlin, 13353 · Germany
- Research SiteNot Yet Recruiting
Essen, 45147 · Germany
- Research SiteNot Yet Recruiting
Frankfurt am Main, 60596 · Germany
- Research SiteNot Yet Recruiting
Würzburg, 97078 · Germany
Terms used on this page · explanations by MedicalUpdates.ai
- informed consent form
- 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.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- ECG
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- magnetic resonance imaging
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- legally authorized representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- 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 website; 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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