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

NCT04611204 | Terminated

• 1 other identifier: RC31/18/0470
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Transthyretin Amyloidosis; Carpal Tunnel Syndrome

Keywords

cardiac amyloidosis; transthyretin amyloidosis; carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• Cardiac involvement

  Prevalence of cardiac involvement in presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released.

  1 day

Secondary Outcomes (1)

• Transthyretin amyloid involvement

  1 day

Interventions

Descriptive cohort OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Interventional transversal monocentric study with prospective recruitment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Olivier Lairez

Toulouse, France

Location

MeSH Terms

Conditions

Amyloidosis, Hereditary, Transthyretin-Related; Carpal Tunnel Syndrome; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Amyloid Neuropathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Olivier LAIREZ, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: October 1, 2020
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

FR (1)