Carpal Tunnel Release With Risk Factors for Amyloidosis

ID studio #: NCT05793320

condizione: amiloidosi

stato: reclutamento

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.

intervento: Chirurgia del rilascio del tunnel carpale

risultati: https://clinicaltrials.gov/ct2/show/results/NCT05793320

ultimo aggiornamento: Dicembre 28, 2023

data d'inizio: 3 Agosto 2023

completamento previsto: Dicembre 3, 2024

ultimo aggiornamento: 7 Novembre 2023

fase di sviluppo: Non Applicabile

taglia / iscrizione: 250

risultati primari:

• Rate of amyloid positivity
  How many patients who participate in study have positive biopsy for amyloidosis.
• Biopsy sent for testing immediately after the procedure
  

criterio di inclusione:

criteri di esclusione: criteri:

Unable or unwilling to follow up with cardiology.
Previous diagnosis of cardiac amyloidosis.

sponsor: Henry Ford Health System

contatti: Logan Hansen, MD, 313-916-2600, [email protected]

investigatori: Charles Day, MD,Henry Ford Health System

sedi dei centri di prova: Stati Uniti

• Stati Uniti, Michigan
  Campus principale di Henry Ford
  Charles S Day, 313-595-6428, [email protected]