Clinical Trial: Carpal Tunnel Release With Risk Factors for Amyloidosis
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis
Brief 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.
Detailed Summary:
Sponsor: Henry Ford Health System
Current Primary Outcome: How many patients who participate in study have positive biopsy for amyloidosis.
Original Primary Outcome: How many patients who participate in study have positive biopsy for amyloidosis.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Henry Ford Health System
Dates:
Date Received: March 16, 2023
Date Started: August 03, 2023
Date Completion: August 03, 2023
Last Updated: November 03, 2023
Last Verified: November 01, 2023