Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

Carpal Tunnel Syndrome Bilateral Clinical Trial

— AMYLYONCARP  

Official title:

Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890119
• Other study ID #: AMYLYONCARP
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: Philippe SCHIELE, MD
• Phone: 478 618 216
• Email: pschiele[@]chsjsl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• bilateral carpal tunnel with indication of surgery and judged suspect:
• age of 50 years old and more
• non-traumatic or undetermined neuropathic etiology or cardiac history (atrial arrhythmia or Heart Failure or cardiac stimulation) or family history of hereditary amyloidosis or monoclonal gammopathy

Exclusion Criteria:

• patient with diagnosis of amyloidosis
• traumatic bilateral carpal tunnel or linked to rheumatoid arthritis

Related Conditions & MeSH terms

• Amyloidosis
• Carpal Tunnel Syndrome
• Carpal Tunnel Syndrome Bilateral

Intervention

Diagnostic Test:
• tenosynovial tissue biopsy
Biopsy of tenosynovial tissue during surgery for amyloid aggregate search

Locations

Country	Name	City	State
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Research of organ amyloidosis (context of standard care): exploratory	Among positive patients, additional exams will be performed in the context of standard care in order to research for organ amyloidosis: blood sampling, EKG, echocardiography and other organ exams according to type of amyloidosis	in the 3 months following surgery
Primary	Prevalence of amyloid aggregate	Research of amyloid aggregate in tenosynovial tissue	During surgery
Secondary	Typing of amyloid aggregate	Caracterization of amyloid aggregate in tenosynovial tissue	During surgery