Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population

NCT ID: NCT05409833

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2025-06-01

Brief Summary

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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

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Conditions

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Transthyretin Amyloidosis Carpal Tunnel Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Patients aged ≥ 60 years old with symptomatic carpal tunnel syndrome submitted to surgery

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis

Interventions

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

Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role collaborator

Centro de Investigação em Tecnologias e Serviços de Saúde

OTHER

Sponsor Role collaborator

Rede de Investigação em Saúde

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabete Martins, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

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Centro Hospitalar Universitário São João

Porto, , Portugal

Site Status RECRUITING

Faculty of Medicine (FMUP)

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Elisabete Martins, MD, PhD

Role: CONTACT

(+351) 965913480

Janete Santos, PhD

Role: CONTACT

(+351) 225 513 600

Facility Contacts

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Elisabete Martins, MD, PhD

Role: primary

(+351) 965913480

Janete Santos, PhD

Role: primary

(+351) 225 513 600

Other Identifiers

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CarPoS

Identifier Type: -

Identifier Source: org_study_id

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