Clinical trial NCT02792790: Carpal Tunnel Syndrome and Amyloid Cardiomyopathy
Official title: Carpal Tunnel Syndrome and Amyloid Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyloidosis
Cardiomyopathy
Transthyretin Amyloidosis
Senile Systemic Amyloidosis
Carpal Tunnel Syndrome
Keywords: Amyloidosis
Carpal tunnel syndrome
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of transthyretin (TTR) amyloidosis in patients undergoing carpal tunnel release surgery
timeFrame: Biopsy completed on day of surgery
measure: Cardiac progression of transthyretin (TTR) amyloidosis in carpal tunnel biopsy-positive patients
timeFrame: 4 years from baseline cardiac assessment.
Secondary outcomes:
measure: Prevalence of abnormal transthyretin (TTR) kinetics in patients undergoing carpal tunnel surgery
timeFrame: One-time kinetics test for biopsy-negative patients; baseline kinetics and annually for 4 years in biopsy-positive patients
measure: Early transthyretin (TTR) amyloid cardiomyopathy identification in carpal tunnel biopsy-positive patients
timeFrame: Baseline and annual testing for 4 years in biopsy-positive patients
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Lutheran Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mazen Hanna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.