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NCT05793320Completed

Carpal Tunnel Release With Risk Factors for Amyloidosis

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

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
250 (actual)
First submitted
16 Mar 2023
Start date
3 Aug 2023
Primary completion date
3 Dec 2025
Lead sponsor
Henry Ford Health System
Diseases
Amyloidosis
NCT number
NCT05793320

What you commit to

  • Study type: Interventional
  • Participants enrolled: 250
  • From 3 Aug 2023 to the primary completion date, 3 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous diagnosis of cardiac amyloidosis.

Other

  • Unable or unwilling to follow up with cardiology.

Who the study is looking for

  • 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)

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Henry Ford Main Campus
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.