Carpal Tunnel Syndrome and Amyloid Cardiomyopathy

NeuroTherapia, Inc.

Status: Completed

Conditions: Transthyretin Amyloidosis; Cardiomyopathy; Carpal Tunnel Syndrome; Amyloidosis; Senile Systemic Amyloidosis

Study type: Observational

Funder types: Other

Identifiers

NCT02792790

16-158

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males ≥ 50 years of age
• Females ≥ 60 years of age
• Undergoing carpal tunnel release surgery (adequate symptoms are not responding to conservative management requiring surgery)
• Able to consent
• Underwent carpal tunnel surgery and biopsy within last 30 days, if the study was discussed prior to surgery by one of the study physicians.

Exclusion criteria

• Secondary CTS (Hemodialysis, rheumatoid arthritis, trauma)
• Known diagnosis of amyloidosis

Trial design

96 participants in 1 patient group

Patients with carpal tunnel syndrome.

Description:

Patients undergoing carpal tunnel release surgery.