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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
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyloidosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 16, 2023
    Last Updated
    March 29, 2023
    Sponsor
    Henry Ford Health System
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    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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