UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061345 |
|---|---|
| Receipt number | R000070191 |
| Scientific Title | A study on the 5-year positivity rate of cardiac amyloidosis in patients with amyloid deposition detected during surgery for carpal tunnel syndrome or trigger finger who were negative for cardiac amyloidosis at the time of surgery |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/21 22:45:40 |
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Basic information
Public title
A study of cardiac amyloidosis 5 years after surgery in patients with amyloid deposition detected during carpal tunnel syndrome or trigger finger surgery
Acronym
5-year Heart Amyloid Follow-up after Hand Surgery
Scientific Title
A study on the 5-year positivity rate of cardiac amyloidosis in patients with amyloid deposition detected during surgery for carpal tunnel syndrome or trigger finger who were negative for cardiac amyloidosis at the time of surgery
Scientific Title:Acronym
-year follow-up study of cardiac amyloidosis in amyloid-positive CTS/trigger finger surgical patients
Region
| Japan |
Condition
Condition
carpal tunnel syndrome, trigger finger, amyloid deposition, cardiac amyloidosis
Classification by specialty
| Cardiology | Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine the proportion of patients who test positive for cardiac amyloidosis at the five-year follow-up assessment, focusing on cases in which histological amyloid deposits were identified during surgery for carpal tunnel syndrome or trigger finger, yet who tested negative for cardiac amyloidosis at the time of surgery.
Basic objectives2
Others
Basic objectives -Others
We will conduct an exploratory analysis of clinical factors associated with the development of a positive result.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of conversion to cardiac amyloidosis at the five-year follow-up assessment
Key secondary outcomes
1. Comparison of the positivity rate between cases of carpal tunnel syndrome and trigger finger
2. Association between positivity and clinical factors such as age, gender, bilateral involvement, involvement of multiple fingers, and spinal stenosis
3. Association between the location and subtype of amyloid deposits at the time of surgery and positivity at the 5-year follow-up
4. Echocardiographic findings, biomarkers, and distribution of 99mTc-PYP myocardial scintigraphy uptake at the 5-year follow-up
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
Patients who underwent surgery for carpal tunnel syndrome or trigger finger at Saiseikai Yamaguchi General Hospital from February 2020 onward.
Patients with amyloid deposition confirmed by pathological examination of tissue collected during surgery.
Patients judged to be negative for cardiac amyloidosis at the time of surgery based on cardiovascular evaluation.
Patients who can be contacted at the time of the 5-year follow-up evaluation.
Patients from whom informed consent for participation in this study can be obtained
Key exclusion criteria
Patients who do not give their consent to participate in the study
Patients for whom it is difficult to obtain the information required for the 5-year follow-up or to carry out the necessary tests
Patients deemed unsuitable by the principal investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Teruyasu |
| Middle name | |
| Last name | Ohno |
Organization
Saiseikai Yamaguchi General Hospital
Division name
Department of Orthopedic Surgery
Zip code
7538517
Address
2-11 Midorimachi, Yamaguchi-Shi, Yamaguchi
TEL
0839016111
teruyasu1970@icloud.com
Public contact
Name of contact person
| 1st name | Teruyasu |
| Middle name | |
| Last name | Ohno |
Organization
Saiseikai Yamaguchi General Hospital
Division name
Department of Orthopedic Surgery
Zip code
7538517
Address
2-11 Midorimachi, Yamaguchi-Shi, Yamaguchi
TEL
0839016111
Homepage URL
teruyasu1970@icloud.com
Sponsor or person
Institute
Saiseikai Yamaguchi General Hospital
Institute
Department
Personal name
Teruyasu Ohno
Funding Source
Organization
This study has no external funding.
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
Saiseikai Yamaguchi General Hospital
Address
2-11 Midorimachi, Yamaguchi-Shi, Yamaguchi
Tel
0839016111
keiri@ymg-saiseikai.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
山口県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | 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. Eligible patients are those who underwent surgery for carpal tunnel syndrome or trigger finger at our hospital from February 2020 onward, had amyloid deposition confirmed in surgically obtained tissue, and were judged negative for cardiac amyloidosis at the time of surgery. Eligible cases will be identified from existing medical records and pathological data, and after informed consent, cardiac amyloidosis positivity at 5 years after surgery will be evaluated. Factors to be explored include age, sex, bilaterality, multiple digit involvement, lumbar spinal stenosis, and the site/subtype of amyloid deposition.
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070191
