Carpal Tunnel Syndrome and Amyloidosis (AMICAR)

January 27, 2020 updated by: Maria del Carmen Navarro-Saez, Corporacion Parc Tauli
Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Carpal tunnel syndrome (CTS) can be caused by the deposition and accumulation of misfolded proteins called amyloid and is often an early manifestation of systemic amyloidosis.

Patients with cardiac amyloidosis often have carpal tunnel syndrome that precedes cardiac manifestations by several years, and many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.

The investigators sought to identify the prevalence and type of amyloid deposits in patients undergoing carpal tunnel surgery and evaluate for cardiac involvement

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria del Carmen Navarro-Saez, M.D.
  • Phone Number: 21990 937 231 010
  • Email: mnavarros@tauli.cat

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Maria Del Carmen Navarro-Saez
        • Contact:
          • Maria del Carmen Navarro-Saez, M.D.
          • Phone Number: 21990 937 231 010
          • Email: mnavarros@tauli.cat
        • Sub-Investigator:
          • Carlos Feijoo-Massó, M.D.
        • Sub-Investigator:
          • Alexandre Berenguer-Sanchez, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing carpal tunnel syndrome surgery

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amyloid
Biopsy
Procedure: Carpal tunnel syndrome surgery
Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery
Time Frame: 2 years
Prevalence of amyloid deposits in biopsy in patients undergoing carpal tunnel syndrome surgery
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with cardiac involvement in echocardiogram
Time Frame: 2 years
Cardiac involment in echocardiography
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2020

Primary Completion (Anticipated)

January 8, 2022

Study Completion (Anticipated)

January 8, 2023

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPT_AMICAR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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