UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058808 |
|---|---|
| Receipt number | R000067249 |
| Scientific Title | Prospective observational study for screening cardiac amyloidosis in patients with synovial amyloid deposition identified during carpal tunnel release surgery |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/15 15:59:02 |
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Basic information
Public title
Screening for cardiac amyloidosis in patients with carpal tuunel syndrome (SCREEN-CTS trial)
Acronym
SCREEN-CTS trial
Scientific Title
Prospective observational study for screening cardiac amyloidosis in patients with synovial amyloid deposition identified during carpal tunnel release surgery
Scientific Title:Acronym
SCREEN-CTS Trial
Region
| Japan |
Condition
Condition
carpal tunnel syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Prevalence and incidence of cardiac amyloidosis in patients undergoing surgery for carpal tunnel syndrome
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence and incidence of cardiac amyloidosis
Key secondary outcomes
Time to diagnosis and treatment adoption rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Wakeyama |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Division of Crdiology
Zip code
745-8522
Address
1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL
+81-834-28-4411
wakeyama@icloud.com
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Wakeyama |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Division of Cardiology
Zip code
745-8522
Address
1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL
+81-834-28-4411
Homepage URL
wakeyama@icloud.com
Sponsor or person
Institute
Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board at Tokuyama Central Hospital
Address
1-1, Kodachou, Shunan, Yamaguchi, Japan
Tel
+81-834-28-4411
chiken2@tokuchuhp.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study (Tokuyama Central Hospital, Department of Orthopedic Surgery/Cardiovascular Medicine)
Management information
Registered date
| 2025 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067249
