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The goal of this study is to develop an algorithm using artificial intelligence (AI) to assist identification of potential ATTR-CM cases using routine transthoracic echocardiography. The main questions it aims to answer are: * is the algorithm able to diagnose ATTR-CM * is the algorithm able to diagnose different types of ATTR-CM (ATTRv, ATTRwt) This is a non interventional study. Participant' echocardiographies will be, after deidentification, used to train, valid and test the algorithm.
Transthyretin (TTR) amyloidosis is a serious systemic disease affecting multiple target organs including the peripheral nervous system, heart, and kidney. In the absence of treatment, the median survival for symptomatic forms with cardiac involvement is 3 to 4 years. In recent years, new treatments have proven their effectiveness in transthyretin amyloidosis, making it possible to slow the progression of neuropathy and cardiac damage. These treatments seem particularly effective when they are initiated at an early stage of the disease. It is therefore necessary to establish the diagnosis as early as possible in order to benefit the most from the treatment. However, during the clinical examination, the electrocardiogram or the routine echocardiography, the signs evoking cardiac amyloidosis are not specific. The initial diagnosis is therefore often difficult, missed or delayed and the median time between the first symptoms and the initiation of treatment is approximately 3 years. It is therefore the initial phase of diagnosis that must be improved in a sufficiently sensitive and specific manner to detect potential cases early while avoiding unnecessary examinations in the event of a low probability. The objective of the study is to develop and validate a tool to assist the screening of cardiac transthyretin amyloidosis, from standard echocardiography, without the need for active participation of the cardiologist in the diagnostic process. This diagnostic contribution will allow the cardiologist to evoke the diagnosis of cardiac amyloidosis and to consider additional explorations.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Bichat
Paris, France
Start Date
January 1, 2022
Primary Completion Date
January 1, 2025
Completion Date
January 1, 2026
Last Updated
March 25, 2024
15,000
ESTIMATED participants
non interventional study
OTHER
Lead Sponsor
Algalarrondo Vincent
Collaborators
NCT07207811
NCT07382128
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07196839