Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population

Recruiting

• Conditions: Transthyretin Amyloidosis; Carpal Tunnel Syndrome
• Interventions: Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD

• Registration Number: NCT05409833
• Lead Sponsor: Universidade do Porto

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD	Patients aged ≥ 60 years old without symptomatic carpal tunnel syndrome submitted to hand surgery
Group 1	Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD	Patients aged ≥ 60 years old with symptomatic carpal tunnel syndrome submitted to surgery

Primary Outcome Measures

Name	Time	Method
Frequency of transthyretin amyloidosis in synovial in patients with ≥60 years old	24 months	Number of patients with transthyretin amyloidosis in synovial in relation to total number of patients submitted to hand surgery

Secondary Outcome Measures

Name	Time	Method
Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis	24 months	Comparison between group 1 and 2
Association between synovial transthyretin amyloidosis with carpal tunnel syndrome	24 months	Comparison between group 1 and 2

Trial Locations

Locations (2)

Centro Hospitalar Universitário São João; 🇵🇹 Porto, Portugal

Faculty of Medicine (FMUP); 🇵🇹 Porto, Portugal