Clinical Trial: Carpal Tunnel Syndrome and Amyloid Cardiomyopathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Carpal Tunnel Syndrome and Amyloid Cardiomyopathy
Brief 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 Summary:
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.
Sponsor: The Cleveland Clinic
Current Primary Outcome: Number of participants with transthyretin (TTR) amyloid deposits in the soft tissue removed during the biopsy of patients undergoing carpal tunnel release surgery for idiopathic CTS. [ Time Frame: One month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients with transthyretin (TTR) amyloid found in the carpal tunnel who are found to have cardiac involvement by echocardiogram or technetium pyrophosphate scintigraphy at the time of biopsy or who develop it over 4 year follow up. [ Time Frame: One month ]
- TTR kinetics in the blood samples of patients undergoing carpal tunnel release surgery. [ Time Frame: One month ]
Original Secondary Outcome: Same as current
Information By: The Cleveland Clinic
Dates:
Date Received: April 20, 2016
Date Started: March 2016
Date Completion: December 2017
Last Updated: March 23, 2017
Last Verified: April 2016
