Carpal Tunnel Release With Risk Factors for Amyloidosis
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
250 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Charles Day, MD; Logan Hansen, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal