Carpal Tunnel Syndrome and Amyloid Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-12-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amyloidosis Cardiomyopathy Transthyretin Amyloidosis Senile Systemic Amyloidosis Carpal Tunnel Syndrome

Keywords

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Amyloidosis Carpal tunnel syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with carpal tunnel syndrome.

Patients undergoing carpal tunnel release surgery.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Mazen Hanna MD

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mazen Hanna, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Lutheran Hospital

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 30336828 (View on PubMed)

Other Identifiers

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16-158

Identifier Type: -

Identifier Source: org_study_id