Carpal Tunnel Release With Risk Factors for Amyloidosis
Primary Purpose
Amyloidosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carpal Tunnel Release Surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Amyloidosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Carpal Tunnel Release
Arm Description
Outcomes
Primary Outcome Measures
Rate of amyloid positivity
How many patients who participate in study have positive biopsy for amyloidosis.
Secondary Outcome Measures
Full Information
NCT ID
NCT05793320
First Posted
March 16, 2023
Last Updated
March 29, 2023
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05793320
Brief Title
Carpal Tunnel Release With Risk Factors for Amyloidosis
Official Title
Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carpal Tunnel Release
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Carpal Tunnel Release Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of amyloid positivity
Description
How many patients who participate in study have positive biopsy for amyloidosis.
Time Frame
Biopsy sent for testing immediately after the procedure
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Males older than 50 years old and females older than 60 years old are eligible.
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hardy Evans, MD
Phone
313-916-2600
Ext
ask for ortho
Email
hevans3@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Day, MD
Phone
3135956428
Email
cday9@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Day, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Carpal Tunnel Release With Risk Factors for Amyloidosis
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