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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04245098
Other study ID # CSPT_AMICAR1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 8, 2020
Est. completion date January 8, 2023

Study information

Verified date January 2020
Source Corporacion Parc Tauli
Contact Maria del Carmen Navarro-Saez, M.D.
Phone 937 231 010
Email mnavarros@tauli.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 8, 2023
Est. primary completion date January 8, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients undergoing carpal tunnel syndrome surgery

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Carpal tunnel syndrome surgery
Biopsy

Locations

Country Name City State
Spain Maria Del Carmen Navarro-Saez Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 years
Secondary Number of participants with cardiac involvement in echocardiogram Cardiac involment in echocardiography 2 years
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