Clinical trial NCT04611204: Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
Official title: Prevalence of Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Transthyretin Amyloidosis
Carpal Tunnel Syndrome
Keywords: cardiac amyloidosis
transthyretin amyloidosis
carpal tunnel syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Interventional transversal monocentric study with prospective recruitment.

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.

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

Primary outcomes:
measure: Cardiac involvement
timeFrame: 1 day
Secondary outcomes:
measure: Transthyretin amyloid involvement
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Olivier Lairez
Study officials:
affiliation: University Hospital, Toulouse
name: Olivier LAIREZ, MD
role: PRINCIPAL_INVESTIGATOR
References: