Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population

NCT05409833 | Unknown

• 1 other identifier: CarPoS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Transthyretin Amyloidosis; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Association between synovial transthyretin amyloidosis with carpal tunnel syndrome

  24 months

• Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis

  24 months

Study Arms (2)

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

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

Interventions

Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD DIAGNOSTIC_TEST

Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis

Group 1; Group 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ≥60 years old submitted to hand surgery

You may qualify if:

• Patients aged ≥ 60 years old with symptomatic idiopathic carpal tunnel syndrome or other hand surgery indications.

You may not qualify if:

• Diabetes mellitus, hypothyroidism, hemodialysis, rheumatoid arthritis, and other inflammatory arthropathies, multiple myeloma, gout, chondrocalcinosis, Colles fracture, space-occupying lesions, and infectious synovitis.

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Rede de Investigação em Saúde: collaborator

Study Sites (2)

Centro Hospitalar Universitário São João

Porto, 4200-319, Portugal

RECRUITING

Faculty of Medicine (FMUP)

Porto, 4200-319, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

biopsy and peripheral blood

MeSH Terms

Conditions

Amyloidosis, Hereditary, Transthyretin-Related; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Elisabete Martins, MD, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabete Martins, MD, PhD

CONTACT

(+351) 965913480; ebernardes@med.up.pt

Janete Santos, PhD

CONTACT

(+351) 225 513 600; investigaclinica@med.up.pt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: June 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-06

Locations

PT (2)