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NCT04611204 Clinical Trial

Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery

Carpal Tunnel Syndrome Clinical Trial

— PRATHYC  

Official title:
Prevalence of Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04611204
Other study ID # RC31/18/0470
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date February 23, 2023

Study information
Verified date February 2024
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. This study will describe the relationship between amyloid deposition observed on the transverse carpal ligament and the presence of cardiac involvement.

Description:

Unrecognized wild-type transthyretin amyloidosis (ATTRwt) in patients with idiopathic carpal tunnel syndrome (CTS) is a prevalent aging-related disorder. Amyloid deposition in the tenosynovial tissue has been reported in ~35% of patients with idiopathic carpal tunnel syndrome. Otherwise, CTS has been shown to be the most common initial symptom of systemic wild-type transthyretin amyloidosis. The clinical significance of subclinical ATTRwt deposits in the heart in elderly patients has yet to be determined, but these deposits could contribute to the development of heart failure with preserved ejection fraction. ATTRwt has been reported in ~15% of patients with heart failure with preserved ejection fraction. Early detection of amyloid deposition in the transverse carpal ligament of patients with CTS could anticipate cardiac damage and progression to heart failure.The aim of this study is to determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date February 23, 2023
Est. primary completion date February 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over 18 year-old - Indication carpal tunnel release surgery of idiopathic carpal tunnel syndrome. - To agree to participate (signature of the informed consent) - Affiliate or beneficiary of a social security scheme Exclusion Criteria: - Patients with non-idiopathic carpal tunnel syndrome with medical contraindication : pregnancy, obesity (body mass index > 30), diabetes, rheumatoid arthritis, sarcoidosis, purulent tenosynovitis, tuberculosis, systemic lupus erythematosus, hypothyroidism or hyperthyroidism and gout. - Patients with history of cardiac disease or coronary artery disease. - Patients with systemic amyloidosis already known. - Patients unde guardianship or curatorship

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Descriptive cohort
NT-proBNP assay, electrocardiogram and transthoracic echocardiography before CTS surgery release. Pathological analysis for amyloid deposits of transverse carpal ligament of patients included.

Locations
Country Name City State
France Olivier Lairez Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac involvement Prevalence of cardiac involvement in presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released. 1 day
Secondary Transthyretin amyloid involvement Prevalence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released. Electrocardiographic features of cardiac involvement in case of presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released. 1 day
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