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NCT05409833 Clinical Trial

Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population

Carpal Tunnel Syndrome Clinical Trial

— CarPoS  

Official title:
Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population (CarPoS Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05409833
Other study ID # CarPoS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2025

Study information
Verified date June 2023
Source Universidade do Porto
Contact Elisabete Martins, MD, PhD
Phone (+351) 965913480
Email ebernardes@med.up.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Systemic transthyretin amyloidosis is an aging-related disorder. It is usually associated with cardiac disease but also extends to other organs. Recent studies found that idiopathic carpal tunnel syndrome patients may have amyloid deposition in tenosynovial tissue. The main aims of this project are the characterization of the association between idiopathic carpal tunnel syndrome and transthyretin amyloidosis and its evaluation as a predictive factor of cardiac amyloidosis

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: . Patients aged = 60 years old with symptomatic idiopathic carpal tunnel syndrome or other hand surgery indications. Exclusion Criteria: . Diabetes mellitus, hypothyroidism, hemodialysis, rheumatoid arthritis, and other inflammatory arthropathies, multiple myeloma, gout, chondrocalcinosis, Colles fracture, space-occupying lesions, and infectious synovitis.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD
Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis

Locations
Country Name City State
Portugal Centro Hospitalar Universitário São João Porto
Portugal Faculty of Medicine (FMUP) Porto

Sponsors (5)
Lead Sponsor Collaborator
Universidade do Porto Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS), Centro Hospitalar Universitário São João, E.P.E. (CHUSJ), Faculty of Medicine (FMUP), Rede de Investigação em Saúde (RISE), Laboratório Associado

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of transthyretin amyloidosis in synovial in patients with =60 years old Number of patients with transthyretin amyloidosis in synovial in relation to total number of patients submitted to hand surgery 24 months
Secondary Association between synovial transthyretin amyloidosis with carpal tunnel syndrome Comparison between group 1 and 2 24 months
Secondary Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis Comparison between group 1 and 2 24 months
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