Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

⁃ Positive screening is defined as two characteristics from Tier 1 or one characteristic from Tier 1 and one from Tier 2 Tier 1

• Male \> 50 years old

• Female \> 60 years old

• Bilateral carpal tunnel symptoms or prior release surgery Tier 2

• Spinal stenosis

• History of biceps tendon rupture

• Atrial fibrillation or flutter (active or previous history)

• Pacemaker

• Congestive heart failure

• Family history of transthyretin amyloidosis (ATTR)

Locations
United States
Michigan
Henry Ford Main Campus
RECRUITING
Detroit
Contact Information
Primary
Logan Hansen, MD
lhansen2@hfhs.org
313-916-2600
Backup
Charles Day, MD
cday9@hfhs.org
3135956428
Time Frame
Start Date: 2023-08-03
Estimated Completion Date: 2024-12-03
Participants
Target number of participants: 250
Treatments
Experimental: Carpal Tunnel Release
Sponsors
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov