RECRUITING

Carpal Tunnel Release With Risk Factors for Amyloidosis

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-03
Study Completion:2024-12-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05793320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male \> 50 years old
  2. * Female \> 60 years old
  3. * Bilateral carpal tunnel symptoms or prior release surgery Tier 2
  4. * Spinal stenosis
  5. * History of biceps tendon rupture
  6. * Atrial fibrillation or flutter (active or previous history)
  7. * Pacemaker
  8. * Congestive heart failure
  9. * Family history of transthyretin amyloidosis (ATTR)
  1. * Unable or unwilling to follow up with cardiology.
  2. * Previous diagnosis of cardiac amyloidosis.

Contacts and Locations

Study Contact

Logan Hansen, MD
CONTACT
313-916-2600
lhansen2@hfhs.org
Charles Day, MD
CONTACT
3135956428
cday9@hfhs.org

Principal Investigator

Charles Day, MD
PRINCIPAL_INVESTIGATOR
Henry Ford Health System

Study Locations (Sites)

Henry Ford Main Campus
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

  • Charles Day, MD, PRINCIPAL_INVESTIGATOR, Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-03
Study Completion Date2024-12-03

Study Record Updates

Study Start Date2023-08-03
Study Completion Date2024-12-03

Terms related to this study

Additional Relevant MeSH Terms

  • Amyloidosis