Carpal Tunnel Release With Risk Factors for Amyloidosis
Status unconfirmed · Not applicable
Conditions studied: Amyloidosis
In brief
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.
Key facts
- Study ID
- NCT05793320
- Run by
- Henry Ford Health System
- People needed
- 250
- Starts
- 2023-08-03
- Expected to finish
- 2024-12-03
- Last updated by the study team
- 2023-11-07
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Unable or unwilling to follow up with cardiology.
- Previous diagnosis of cardiac amyloidosis.
Where it is running
- Henry Ford Main Campus — Detroit, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.