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Completed NCT05793320

Carpal Tunnel Release With Risk Factors for Amyloidosis

Conditions: Amyloidosis

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 250
Sponsor: Henry Ford Health System

Location: Henry Ford Main Campus Detroit Michigan

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05793320). StuddyBuddy aggregates publicly available trial information.