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Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05409833
Acronym
CarPoS
Enrollment
100
Registered
2022-06-08
Start date
2020-06-01
Completion date
2025-06-01
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Transthyretin Amyloidosis

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

Interventions

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

Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis

Sponsors

Centro Hospitalar De São João, E.P.E.
CollaboratorOTHER
Centro de Investigação em Tecnologias e Serviços de Saúde
CollaboratorOTHER
Rede de Investigação em Saúde
CollaboratorOTHER
Universidade do Porto
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of transthyretin amyloidosis in synovial in patients with ≥60 years old24 monthsNumber of patients with transthyretin amyloidosis in synovial in relation to total number of patients submitted to hand surgery

Secondary

MeasureTime frameDescription
Association between synovial transthyretin amyloidosis with carpal tunnel syndrome24 monthsComparison between group 1 and 2
Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis24 monthsComparison between group 1 and 2

Countries

Portugal

Contacts

Primary ContactElisabete Martins, MD, PhD
ebernardes@med.up.pt(+351) 965913480
Backup ContactJanete Santos, PhD
investigaclinica@med.up.pt(+351) 225 513 600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026