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Trial record 2 of 188 for:    Carpal Tunnel Syndrome

Carpal Tunnel Syndrome and Amyloid Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT02792790
Recruitment Status : Active, not recruiting
First Posted : June 8, 2016
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mazen Hanna MD, The Cleveland Clinic

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.

Condition or disease
Amyloidosis Cardiomyopathy Transthyretin Amyloidosis Senile Systemic Amyloidosis Carpal Tunnel Syndrome

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.


Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Patients with carpal tunnel syndrome.
Patients undergoing carpal tunnel release surgery.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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
Blood will be stored in Cleveland Clinic to be used for the future studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing carpal tunnel release surgery for idiopathic carpal tunnel syndrome not responding conservative and medical management.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792790


Locations
United States, Ohio
Lutheran Hospital
Cleveland, Ohio, United States, 44113
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Mazen Hanna, MD The Cleveland Clinic

Responsible Party: Mazen Hanna MD, Prinicipal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02792790     History of Changes
Other Study ID Numbers: 16-158
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mazen Hanna MD, The Cleveland Clinic:
Amyloidosis
Carpal tunnel syndrome

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Cardiomyopathies
Amyloidosis
Amyloid Neuropathies, Familial
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Amyloid Neuropathies
Genetic Diseases, Inborn
Amyloidosis, Familial
Metabolism, Inborn Errors