- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139797
Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases (EchoNet-Screening)
Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Centre (Los Angeles)
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Contact:
- David Ouyang, MD
- Phone Number: 832-495-1605
- Email: david.ouyang@cshs.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Artificial Intelligence Screening for Cardiac Amyloidosis
An artificial intelligence algorithm will produce a probability of cardiac amyloidosis that will trigger referral to specialty clinic for further evaluation.
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An AI algorithm identifies LVH, low voltage, and high suspicion for cardiac amyloidosis.
The intervention is the suspicion score.
Patients with high suspicion score will be referred to specialty clinic for standard of care evaluation, screening, and treatment as determined by physicians.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of New Diagnoses of Cardiac Amyloidosis Found
Time Frame: 6 months
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From chart review, identification of patients who have a downstream diagnosis of cardiac amyloidosis
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of New Diagnoses of TTR Amyloidosis Found
Time Frame: 6 months
|
From chart review, identification of patients who have a downstream diagnosis of TTR amyloidosis
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6 months
|
Number of New Diagnoses of AL Amyloidosis Found
Time Frame: 6 months
|
From chart review, identification of patients who have a downstream diagnosis of AL amyloidosis
|
6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Amyloidosis
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University Hospital, ToulouseTerminatedCardiac AmyloidosisFrance
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Stanford UniversityCompleted
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University Hospital Center of MartiniqueTerminated
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Pr. Nicolas GIRERDRecruitingTransthyretin Cardiac AmyloidosisFrance
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Mayo ClinicCompletedTTR Cardiac AmyloidosisUnited States
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Poitiers University HospitalPfizerCompletedTransthyretin Cardiac AmyloidosisFrance
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Assiut UniversityNot yet recruiting
Clinical Trials on EchoNet-LVH screening for cardiac amyloidosis
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University of LeipzigActive, not recruitingHeart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Preserved Ejection Fraction | Hypertrophy, Left Ventricular | Heart Failure NYHA Class IV | Cardiac Amyloidosis | Heart Failure With Mid Range Ejection FractionGermany
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Foundation for Sarcoidosis ResearchRecruitingSarcoidosis | Cardiac Sarcoidosis | Boeck's Disease | Besnier-Boeck DiseaseUnited States, United Kingdom, Netherlands
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Sophie JACOBInstitut Curie; Centre Francois Baclesse; Clinique Pasteur ToulouseRecruitingBreast Cancer | Atrial Fibrillation | Radiation Toxicity | Cardiac Arrhythmia | Cardiac DiseaseFrance