Carpal Tunnel Release With Risk Factors for Amyloidosis

Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793320
• Other study ID #: 16239-01
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: December 3, 2024

Study information

• Verified date: November 2023
• Source: Henry Ford Health System
• Contact: Logan Hansen, MD
• Phone: 313-916-2600
• Email: lhansen2[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 3, 2024
• Est. primary completion date: August 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

• Unable or unwilling to follow up with cardiology.

• Previous diagnosis of cardiac amyloidosis.

Related Conditions & MeSH terms

• Amyloidosis

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Main Campus	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of amyloid positivity	How many patients who participate in study have positive biopsy for amyloidosis.	Biopsy sent for testing immediately after the procedure