Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793320
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-03-16
Brief Title:
Carpal Tunnel Release With Risk Factors for Amyloidosis
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None