Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058808) titled 'Screening for cardiac amyloidosis in patients with carpal tuunel syndrome (SCREEN-CTS trial)' on Aug. 15.
Study Type:
Observational
Primary Sponsor:
Institute - Japan Community Healthcare Organization Tokuyama Central Hospital
Condition:
Condition - carpal tunnel syndrome
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We aimed to investigate the frequency of amyloid deposition in synovial tissue and evaluate the prevalence of cardiac amyloidosis in patients who underwent carpal tunnel release at our hospital.
Furthermore, because patients without cardiac amyloidosis are thought to be at high risk in the future, we decided to conduct regular cardiac screening and investigate the distant (5-10 years) incidence of cardiac amyloidosis and factors that predispose to its development.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Patients who underwent carpal tunnel release surgery at the Department of Orthopedic Surgery, Tokuyama Central Hospital.
(2) Patients who consented to a synovial tissue pathology examination.
Key exclusion criteria - (1) Patients diagnosed with cardiac amyloidosis before undergoing carpal tunnel release.
(2) Patients diagnosed with AL amyloidosis (primary amyloidosis), dialysis-associated amyloidosis, pregnant patients, and patients with fractures or injuries.
(3) Patients with dementia for whom it is difficult to obtain consent.
Target Size - 200
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 08 Month 15 Day
Date of IRB - 2025 Year 08 Month 06 Day
Anticipated trial start date - 2025 Year 08 Month 15 Day
Last follow-up date - 2035 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067249
Disclaimer: Curated by HT Syndication.