UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036996 |
|---|---|
| Receipt number | R000042152 |
| Scientific Title | regarding the relation between visual improvement and increased chrioretinal blood flow after cervical carotid revascularization |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2024/12/09 11:38:35 |
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Basic information
Public title
regarding the relation between visual improvement and increased chrioretinal blood flow after cervical carotid revascularization
Acronym
regarding the relation between visual improvement and increased chrioretinal blood flow after cervical carotid revascularization
Scientific Title
regarding the relation between visual improvement and increased chrioretinal blood flow after cervical carotid revascularization
Scientific Title:Acronym
regarding the relation between visual improvement and increased chrioretinal blood flow after cervical carotid revascularization
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
visual improvement and increased chorioretinal blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual improvement and increased chorioretinal blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
acessment of chorioretinal blood flow confirmed by Last speckel flowgraphy
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients having carotid endarterectomy or carotid stunting for carotid artery stenosis
Key exclusion criteria
severe ophthalmologic disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Yoshida |
Organization
Saitama medical center / saitama medical university
Division name
department of neurosurgery
Zip code
3508550
Address
kamoda, kawagoe, saitama
TEL
0492283659
sin-yosida@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Yoshida |
Organization
Saitama medical center / saitama medical university
Division name
department of neurosurgery
Zip code
3508550
Address
kamoda, kawagoe, saitama
TEL
0492283659
Homepage URL
sin-yosida@umin.ac.jp
Sponsor or person
Institute
Saitama medical center / saitama medical university
Institute
Department
Personal name
Funding Source
Organization
Saitama medical center / saitama medical university
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
Saitama medical center / saitama medical university
Address
kamoda, kawagoe, saitama
Tel
0492283659
sin-yosida@umin.ac.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
| 2019 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was completed after enrolling the required cases.
Management information
Registered date
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042152
