Carpal Tunnel Syndrome and Amyloid Cardiomyopathy

NCT02792790 | Completed

• 1 other identifier: 16-158
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Amyloidosis; Carpal tunnel syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• Prevalence of abnormal transthyretin (TTR) kinetics in patients undergoing carpal tunnel surgery

  One-time kinetics test for biopsy-negative patients; baseline kinetics and annually for 4 years in biopsy-positive patients

• Early transthyretin (TTR) amyloid cardiomyopathy identification in carpal tunnel biopsy-positive patients

  Baseline and annual testing for 4 years in biopsy-positive patients

Study Arms (1)

Patients with carpal tunnel syndrome.

Patients undergoing carpal tunnel release surgery.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Lutheran Hospital

Cleveland, Ohio, 44113, United States

Location

Related Publications (1)

• 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.

  PMID: 30336828 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Amyloidosis; Cardiomyopathies; Amyloidosis, Hereditary, Transthyretin-Related; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Mazen Hanna, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: June 8, 2016
• Study Start: March 1, 2016
• Primary Completion: July 21, 2021
• Study Completion: December 2, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)