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

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

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

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Transthyretin Amyloidosis
• Intervention / Treatment: Diagnostic test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Elisabete Martins, MD, PhD; Phone Number: (+351) 965913480; Email: ebernardes@med.up.pt
• Study Contact Backup: Name: Janete Santos, PhD; Phone Number: (+351) 225 513 600; Email: investigaclinica@med.up.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Recruiting
    • Centro Hospitalar Universitario Sao Joao
    • Contact: Elisabete Martins, MD, PhD; Phone Number: (+351) 965913480; Email: ebernardes@med.up.pt
    • Principal Investigator: Elisabete Martins, MD, PhD
    • Sub-Investigator: Sofia Pimenta, MD
  • Porto, Portugal, 4200-319
    • Recruiting
    • Faculty of Medicine (FMUP)
    • Contact: Janete Santos, PhD; Phone Number: (+351) 225 513 600; Email: investigaclinica@med.up.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ≥60 years old submitted to hand surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients aged ≥ 60 years old with symptomatic carpal tunnel syndrome submitted to surgery	Diagnostic test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD; Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis
Group 2; Patients aged ≥ 60 years old without symptomatic carpal tunnel syndrome submitted to hand surgery	Diagnostic test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD; Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between synovial transthyretin amyloidosis with carpal tunnel syndrome	Comparison between group 1 and 2	24 months
Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis	Comparison between group 1 and 2	24 months

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Centro Hospitalar Universitário São João, E.P.E. (CHUSJ); Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS); Rede de Investigação em Saúde (RISE), Laboratório Associado; Faculty of Medicine (FMUP)
• Investigators: Principal Investigator: Elisabete Martins, MD, PhD, Faculty of Medicine (FMUP)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Wounds and Injuries; Disease; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Proteostasis Deficiencies; Metabolism, Inborn Errors; Heredodegenerative Disorders, Nervous System; Amyloidosis, Familial; Amyloid Neuropathies; Syndrome; Carpal Tunnel Syndrome; Amyloidosis; Amyloid Neuropathies, Familial
• Other Study ID Numbers: CarPoS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No