Skip to main content
OpenTrials
Completed

NCT Number: NCT05793320

Carpal Tunnel Release With Risk Factors for Amyloidosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Main Campus

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carpal tunnel release surgery

Procedure

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 outcomes

  1. Rate of amyloid positivity

    Time frame: Biopsy sent for testing immediately after the procedure

    How many patients who participate in study have positive biopsy for amyloidosis.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2023
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.