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Carpal Tunnel Release With Risk Factors for Amyloidosis

NCT05793320 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-11-07

No results posted yet for this study

Summary

Bilateral carpal tunnel syndrome has been demonstrated in previous literature to be a warning sign for potential amyloidosis. One study has been performed in which patients with bilateral carpal tunnel syndrome underwent tissue biopsy (either tendon sheath or transverse carpal ligament) at the time of carpal tunnel release to determine the strength of association as well as most common subtypes. However, no study has been done demonstrating whether or not patients with amyloid-positive carpal tunnel biopsy would benefit from an early referral to cardiology for a work-up of potential cardiac amyloidosis. In our study, patients with bilateral carpal tunnel symptoms who are indicated for carpal tunnel release would be identified in clinic and undergo biopsy for congo red staining at the time of surgery. All patients with positive biopsy results would be referred to cardiology. Outcomes would include the rate of amyloid positivity, common subtypes, and echocardiographic findings after cardiac referral.

Conditions

  • Amyloidosis

Interventions

PROCEDURE

Carpal Tunnel Release Surgery

Carpal tunnel release surgery used to take a biopsy to diagnose amyloidosis and determine whether or not carpal tunnel syndrome can predict who's at risk for having amyloidosis.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Charles Day, MD · Henry Ford Health System

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2024-08-03
Completion
2024-12-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793320 on ClinicalTrials.gov