Carpal Tunnel Release Surgery for Amyloidosis

Recruiting in Palo Alto (17 mi)

Overseen byCharles Day, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Henry Ford Health System

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Charles Day, MD

Principal Investigator

Henry Ford Health System

Eligibility Criteria

This trial is for people over 50 (men) or 60 (women) with bilateral carpal tunnel symptoms, a family history of ATTR, heart issues like congestive heart failure or atrial fibrillation, spinal stenosis, pacemaker, or biceps tendon rupture. They must not have been previously diagnosed with cardiac amyloidosis and be willing to follow up with cardiology.

Inclusion Criteria

I have or had atrial fibrillation/flutter.

I have symptoms of carpal tunnel in both hands or had surgery for it.

I have been diagnosed with congestive heart failure.

See 7 more

Exclusion Criteria

Unable or unwilling to follow up with cardiology

I have been diagnosed with cardiac amyloidosis before.

Treatment Details

Interventions

Carpal Tunnel Release Surgery (Procedure)

Trial OverviewThe study tests if patients undergoing carpal tunnel release surgery who are found to have amyloid deposits benefit from early cardiology referral for potential cardiac amyloidosis. It involves biopsy during surgery and subsequent echocardiographic monitoring after referral.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Carpal Tunnel ReleaseExperimental Treatment1 Intervention