Amyloidosis
Conditions
Brief summary
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.
Interventions
PROCEDURECarpal Tunnel Release Surgery
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.
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of amyloid positivity | Biopsy sent for testing immediately after the procedure | How many patients who participate in study have positive biopsy for amyloidosis. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharles Day, MD
Henry Ford Health System
Outcome results
None listed