Trials / Completed

CompletedNCT02792790

Carpal Tunnel Syndrome and Amyloid Cardiomyopathy

Status: Completed
Phase: —
Study type: Observational
Enrollment: 96 (actual)

Sponsor: The Cleveland Clinic · Academic / Other
Sex: All
Age: 50 Years
Healthy volunteers: Not accepted

Summary

The investigators will prospectively evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid in the soft tissue that is removed. Patients who have tissue that stains positive for amyloid will undergo cardiac testing to look for evidence of cardiac involvement.

Detailed description

Since the 1970s, the connection between amyloidosis and carpal tunnel syndrome has been described, with tenosynovial tissue staining positive for amyloid fibril deposition. Up to 30% of patients in prior studies with idiopathic carpal tunnel syndrome have biopsy tissue that stains positive for amyloid deposition. However, the prevalence of cardiac involvement at the time of carpal tunnel syndrome surgery has not been established. Furthermore, the role of TTR kinetic stability in the disease progression of amyloidosis is unclear. Diagnosing TTR amyloidosis at the time of carpal tunnel involvement could lead to an earlier identification of the disease at a stage where the cardiomyopathy may be occult or less advanced. In addition, abnormal TTR kinetics may even precede tissue deposition in the flexor tendon retinaculum. As several emerging pharmacological strategies are in development that may slow or even halt TTR amyloidosis, earlier diagnosis is advantageous. Identification and implementation of therapy for prevention or early disease treatment may alter the natural history of this progressive systemic disease.

Conditions

Timeline

Start date: 2016-03-01
Primary completion: 2021-07-21
Completion: 2021-12-02
First posted: 2016-06-08
Last updated: 2021-12-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02792790. Inclusion in this directory is not an endorsement.