ClinicalTrials.gov record NCT05139797
Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases (EchoNet-Screening)
Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases
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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 uses an AI algorithm called EchoNet-LVH to flag echocardiograms with left ventricular hypertrophy and a high suspicion for cardiac amyloidosis. People flagged by the algorithm are referred to a specialty clinic and investigators will review records to see who receives a downstream diagnosis over six months. The study evaluates how often AI-guided screening identifies new cases of cardiac amyloidosis.
What it is studying. The study is testing whether the EchoNet-LVH artificial intelligence algorithm can detect echocardiogram patterns that should prompt further evaluation for cardiac amyloidosis and related conditions. It prospectively evaluates whether people flagged by the algorithm go on to receive a diagnosis of cardiac amyloidosis.
What the researchers hope to learn. To evaluate the accuracy of the EchoNet-LVH AI algorithm in identifying echocardiograms that warrant further evaluation for cardiac amyloidosis. To measure how many new diagnoses of cardiac amyloidosis (including TTR and AL subtypes) are found after AI-guided referral. To explore whether AI can improve precision in cardiac phenotyping and disease screening.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Despite rapidly advancing developments in targeted therapeutics and genetic sequencing, persistent limits in the accuracy and throughput of clinical phenotyping has led to a widening gap between the potential and the actual benefits realized by precision medicine. Recent advances in machine learning and image processing techniques have shown that machine learning models can identify features unrecognized by human experts and more precisely/accurately assess common measurements made in clinical practice. The investigators have developed an algorithm, termed EchoNet-LVH, to identify cardiac hypertrophy and identify patients who would benefit from additional screening for cardiac amyloidosis and will prospectively evaluate its accuracy in identifying patients whom would benefit from additional screening for cardiac amyloidosis.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- EchoNet-LVH screening for cardiac amyloidosis
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients who have a high suspicion for cardiac amyloidosis by AI algorithm
Exclusion criteria
- Patients who decline to be seen at specialty clinic
- Patients who have passed away
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Despite rapidly advancing developments in targeted therapeutics and genetic sequencing, persistent limits in the accuracy and throughput of clinical phenotyping has led to a widening gap between the potential and the actual benefits realized by precision medicine. This conundrum is exemplified by current approaches to assessing morphologic alterations of the heart. If reliably identified, certain cardiac diseases (e.g. cardiac amyloidosis and hypertrophic cardiomyopathy) could avoid misdiagnosis and receive efficient treatment initiation with specific targeted therapies. The ability to reliably distinguish between cardiac disease types of similar morphology but different etiology would also enhance specificity for linking genetic risk variants and determining mechanisms Recent advances in machine learning and image processing techniques have shown that machine learning models can identify features unrecognized by human experts and more precisely/accurately assess common measurements made in clinical practice. In echocardiography, this ability for precision measurement and detection is important in both disease screening as well as diagnosis of cardiovascular disease. Echocardiography is routinely and frequently used for diagnosis and prognostication in routine clinical care, however there is often subjectivity in interpretation and heterogeneity in application. Human attention is fatigable and has heterogenous interpretation between providers. AI guided disease screening workflows have been proposed for rare diseases such as cardiac amyloidosis and other diseases with relatively low prevalence but significant human impact with targeted therapies when detected early. This is an area particularly suitable for AI as there are multiple mimics where diseases like hypertrophic cardiomyopathy, cardiac amyloidosis, aortic stenosis, and other phenotypes might visually be similar but can be distinguished by AI algorithms. The investigators have developed an algorithm, termed EchoNet-LVH, to identify cardiac hypertrophy and identify patients who would benefit from additional screening for cardiac amyloidosis, hypertrophic cardiomyopathy and other diseases. E
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.
The EchoNet-LVH artificial intelligence algorithm will be used to produce a suspicion score for cardiac amyloidosis; participants are those identified with a high suspicion score. Patients with a high suspicion score will be referred to a specialty clinic for further evaluation, screening, and any treatment the treating physicians decide is appropriate. The study team will review medical records over a 6-month period to identify any new diagnoses of cardiac amyloidosis (including TTR or AL subtypes). The registry does not list other specific tests or procedures that the study will perform at the specialty clinic.
How the study is structured. A prospective observational cohort. The EchoNet-LVH AI produces a suspicion score from echocardiogram data. Patients with a high suspicion score are referred to a specialty clinic for standard-of-care evaluation. Investigators will review medical records over a six-month period to count new diagnoses, including transthyretin (TTR) and AL amyloidosis.
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 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 ATTRv amyloidosis
This trial is also listed on this site under wild-type ATTR amyloidosis.
Important dates
- Study start
- Nov 18, 2021
- Primary completion
- Jan 1, 2027 (estimated)
- Study completion
- Jun 1, 2027 (estimated)
- Target enrollment
- 300 participants (estimated)
- Last updated on registry
- Jul 22, 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
- Cedars-Sinai Medical Center
- Principal investigator
- Lily Stern, Staff Physician
Cedars-Sinai Medical Center
Participating sites (1)
- Cedars-Sinai Medical Centre (Los Angeles)Recruiting
Los Angeles, California, 90048 · United States
- Lily Stern, MD · (310) 248-8300 · lily.stern@cshs.org
Terms used on this page · explanations by MedicalUpdates.ai
- 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.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
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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