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

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

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.

Study Overview

• Status: Terminated
• Conditions: Carpal Tunnel Syndrome; Transthyretin Amyloidosis
• Intervention / Treatment: Other: Descriptive cohort

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.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Olivier Lairez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Interventional transversal monocentric study with prospective recruitment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transthyretin amyloid involvement	Prevalence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released. Electrocardiographic features of cardiac involvement in case of presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Olivier LAIREZ, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; cardiac amyloidosis; transthyretin amyloidosis
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Proteostasis Deficiencies; Syndrome; Carpal Tunnel Syndrome; Amyloidosis
• Other Study ID Numbers: RC31/18/0470

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No