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

Sponsor

Universidade do Porto (Other)

Overall Status

Recruiting

CT.gov ID

NCT05409833

Collaborator

Faculdade de Medicina da Universidade do Porto (FMUP) (Other), Centro Hospitalar De São João, E.P.E. (Other)

100

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Transthyretin Amyloidosis Carpal Tunnel Syndrome	Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Association between synovial transthyretin amyloidosis with carpal tunnel syndrome [24 months]
Comparison between group 1 and 2
Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis [24 months]
Comparison between group 1 and 2

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Hospitalar Universitário São João	Porto		Portugal	4200-319

Sponsors and Collaborators

Universidade do Porto
Faculdade de Medicina da Universidade do Porto (FMUP)
Centro Hospitalar De São João, E.P.E.

Investigators

Principal Investigator: Elisabete Martins, MD, PhD, Centro Hospitalar São João, EPE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universidade do Porto

ClinicalTrials.gov Identifier:

NCT05409833

Other Study ID Numbers:

CarPoS

First Posted:

Jun 8, 2022

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Amyloid Neuropathies, Familial

Amyloidosis

Syndrome

Study Results

No Results Posted as of Jun 8, 2022