Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery

NCT ID: NCT04611204

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-02-23

Brief Summary

This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. This study will describe the relationship between amyloid deposition observed on the transverse carpal ligament and the presence of cardiac involvement.

Detailed Description

Unrecognized wild-type transthyretin amyloidosis (ATTRwt) in patients with idiopathic carpal tunnel syndrome (CTS) is a prevalent aging-related disorder. Amyloid deposition in the tenosynovial tissue has been reported in ~35% of patients with idiopathic carpal tunnel syndrome.

Otherwise, CTS has been shown to be the most common initial symptom of systemic wild-type transthyretin amyloidosis. The clinical significance of subclinical ATTRwt deposits in the heart in elderly patients has yet to be determined, but these deposits could contribute to the development of heart failure with preserved ejection fraction. ATTRwt has been reported in ~15% of patients with heart failure with preserved ejection fraction. Early detection of amyloid deposition in the transverse carpal ligament of patients with CTS could anticipate cardiac damage and progression to heart failure.The aim of this study is to determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome.

Conditions

Transthyretin Amyloidosis; Carpal Tunnel Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Descriptive cohort

NT-proBNP assay, electrocardiogram and transthoracic echocardiography before CTS surgery release. Pathological analysis for amyloid deposits of transverse carpal ligament of patients included.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients over 18 year-old
• Indication carpal tunnel release surgery of idiopathic carpal tunnel syndrome.
• To agree to participate (signature of the informed consent)
• Affiliate or beneficiary of a social security scheme

Exclusion Criteria

• Patients with non-idiopathic carpal tunnel syndrome with medical contraindication : pregnancy, obesity (body mass index > 30), diabetes, rheumatoid arthritis, sarcoidosis, purulent tenosynovitis, tuberculosis, systemic lupus erythematosus, hypothyroidism or hyperthyroidism and gout.
• Patients with history of cardiac disease or coronary artery disease.
• Patients with systemic amyloidosis already known.
• Patients unde guardianship or curatorship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier LAIREZ, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Olivier Lairez

Toulouse, , France

Countries

France

Other Identifiers

RC31/18/0470

Identifier Type: -

Identifier Source: org_study_id