Carpal Tunnel Syndrome and Amyloid Cardiomyopathy
|ClinicalTrials.gov Identifier: NCT02792790|
Recruitment Status : Active, not recruiting
First Posted : June 8, 2016
Last Update Posted : January 11, 2018
|Condition or disease|
|Amyloidosis Cardiomyopathy Transthyretin Amyloidosis Senile Systemic Amyloidosis Carpal Tunnel Syndrome|
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.
|Study Type :||Observational|
|Actual Enrollment :||96 participants|
|Official Title:||Carpal Tunnel Syndrome and Amyloid Cardiomyopathy|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Patients with carpal tunnel syndrome.
Patients undergoing carpal tunnel release surgery.
- Incidence of transthyretin (TTR) amyloidosis in patients undergoing carpal tunnel release surgery [ Time Frame: Biopsy completed on day of surgery ]Identify the incidence of TTR amyloid deposits in the soft tissue of patients undergoing carpal tunnel surgery for idiopathic carpal tunnel syndrome
- Cardiac progression of transthyretin (TTR) amyloidosis in carpal tunnel biopsy-positive patients [ Time Frame: 4 years from baseline cardiac assessment. ]Assess the progression of cardiac disease in patients with TTR deposits found in soft tissue removed at the time of carpal tunnel surgery
- Prevalence of abnormal transthyretin (TTR) kinetics in patients undergoing carpal tunnel surgery [ Time Frame: One-time kinetics test for biopsy-negative patients; baseline kinetics and annually for 4 years in biopsy-positive patients ]Identify the prevalence of abnormal TTR kinetics in patients undergoing carpal tunnel surgery for idiopathic carpal tunnel syndrome (develop a new test that aids identification of misfolded TTR intermediates that is more specific and sensitive to diagnosis this disease in the blood or tissue)
- Early transthyretin (TTR) amyloid cardiomyopathy identification in carpal tunnel biopsy-positive patients [ Time Frame: Baseline and annual testing for 4 years in biopsy-positive patients ]Investigate whether early TTR cardiomyopathy can be identified in patients who have TTR amyloid deposits identified in the soft tissue removed at the time of carpal tunnel surgery using cardiac biomarkers, echocardiography with strain, and nuclear bone scintigraphy
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792790
|United States, Ohio|
|Cleveland, Ohio, United States, 44113|
|Principal Investigator:||Mazen Hanna, MD||The Cleveland Clinic|