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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with carpal tunnel syndrome. | Patients undergoing carpal tunnel release surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of transthyretin (TTR) amyloidosis in patients undergoing carpal tunnel release surgery | Identify the incidence of TTR amyloid deposits in the soft tissue of patients undergoing carpal tunnel surgery for idiopathic carpal tunnel syndrome | Biopsy completed on day of surgery |
| Cardiac progression of transthyretin (TTR) amyloidosis in carpal tunnel biopsy-positive patients | Assess the progression of cardiac disease in patients with TTR deposits found in soft tissue removed at the time of carpal tunnel surgery | 4 years from baseline cardiac assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of abnormal transthyretin (TTR) kinetics in patients undergoing carpal tunnel surgery | 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) | One-time kinetics test for biopsy-negative patients; baseline kinetics and annually for 4 years in biopsy-positive patients |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing carpal tunnel release surgery for idiopathic carpal tunnel syndrome not responding conservative and medical management.
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| Name | Affiliation | Role |
|---|---|---|
| Mazen Hanna, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lutheran Hospital | Cleveland | Ohio | 44113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30336828 | Derived | Sperry BW, Reyes BA, Ikram A, Donnelly JP, Phelan D, Jaber WA, Shapiro D, Evans PJ, Maschke S, Kilpatrick SE, Tan CD, Rodriguez ER, Monteiro C, Tang WHW, Kelly JW, Seitz WH Jr, Hanna M. Tenosynovial and Cardiac Amyloidosis in Patients Undergoing Carpal Tunnel Release. J Am Coll Cardiol. 2018 Oct 23;72(17):2040-2050. doi: 10.1016/j.jacc.2018.07.092. |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| D009202 | Cardiomyopathies |
| C567782 | Amyloidosis, Hereditary, Transthyretin-Related |
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006331 | Heart Diseases |
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Blood will be stored in Cleveland Clinic to be used for the future studies.
| Early transthyretin (TTR) amyloid cardiomyopathy identification in carpal tunnel 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 | Baseline and annual testing for 4 years in biopsy-positive patients |
| D002318 | Cardiovascular Diseases |
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |