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Carpal Tunnel Syndrome and Amyloidosis (AMICAR)

Primary Purpose

Amyloidosis, Carpal Tunnel Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Carpal tunnel syndrome surgery

About this trial

This is an interventional diagnostic trial for Amyloidosis focused on measuring carpal tunnel syndrome, amyloidosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients undergoing carpal tunnel syndrome surgery

Exclusion Criteria:

None

Sites / Locations

Maria Del Carmen Navarro-SaezRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amyloid

Arm Description

Biopsy

Outcomes

Primary Outcome Measures

Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery

Prevalence of amyloid deposits in biopsy in patients undergoing carpal tunnel syndrome surgery

Secondary Outcome Measures

Number of participants with cardiac involvement in echocardiogram

Cardiac involment in echocardiography

Full Information

NCT ID

NCT04245098

First Posted

January 22, 2020

Last Updated

January 27, 2020

Sponsor

Corporacion Parc Tauli

1. Study Identification

Unique Protocol Identification Number

NCT04245098

Brief Title

Carpal Tunnel Syndrome and Amyloidosis

Acronym

AMICAR

Official Title

Carpal Tunnel Syndrome and Amyloidosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 8, 2020 (Actual)

Primary Completion Date

January 8, 2022 (Anticipated)

Study Completion Date

January 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyloidosis, Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome, amyloidosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amyloid

Arm Type

Experimental

Arm Description

Biopsy

Intervention Type

Procedure

Intervention Name(s)

Carpal tunnel syndrome surgery

Intervention Description

Biopsy

Primary Outcome Measure Information:

Title

Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery

Description

Prevalence of amyloid deposits in biopsy in patients undergoing carpal tunnel syndrome surgery

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Number of participants with cardiac involvement in echocardiogram

Description

Cardiac involment in echocardiography

Time Frame

2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing carpal tunnel syndrome surgery Exclusion Criteria: None

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria del Carmen Navarro-Saez, M.D.

Phone

937 231 010

Ext

21990

mnavarros@tauli.cat

Facility Information:

Facility Name

Maria Del Carmen Navarro-Saez

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria del Carmen Navarro-Saez, M.D.

Phone

937 231 010

Ext

21990

mnavarros@tauli.cat

First Name & Middle Initial & Last Name & Degree

Carlos Feijoo-Massó, M.D.

First Name & Middle Initial & Last Name & Degree

Alexandre Berenguer-Sanchez, M.D

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Carpal Tunnel Syndrome and Amyloidosis

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