UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040228 |
|---|---|
| Receipt number | R000045890 |
| Scientific Title | Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2024/04/26 14:09:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Acronym
Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Scientific Title
Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Scientific Title:Acronym
Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Region
| Japan |
Condition
Condition
Carotid artery stenosis
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of CEA and CAS on equilibrium function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in subjective symptoms and neurootolonical/neuroophthalmological test results
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with carotid artery stenosis requiring CEA or CAS
Key exclusion criteria
Patients who cannot be tested (such as dementia and paresis)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Johkura |
Organization
Yokohama Brain and Spine Center
Division name
Neurology and Stroke Center
Zip code
235-0012
Address
1-2-1 Takigashira, Isogo-ku, Yokohama, Japan
TEL
045-753-2500
ke00-johkura@city.yokohama.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Johkura |
Organization
Yokohama Brain and Spine Center
Division name
Ethics Committee
Zip code
235-0012
Address
1-2-1 Takigashira, Isogo-ku, Yokohama, Japan
TEL
045-753-2500
Homepage URL
ke00-johkura@city.yokohama.jp
Sponsor or person
Institute
Yokohama Brain and Spine Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Yokohama Brain and Spine Center
Address
1-2-1 Takigashira, Isogo-ku, Yokohama, Japan
Tel
045-753-2500
by-no-soumu@city.yokohama.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
| 2020 | Year | 05 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NoneQuestionnaire, vestibulo-ocular reflex, vestibular evoked myogenic potential, Gravicoder, eye tracking test, Carotid untrasonography, SPECT, MRI
Management information
Registered date
| 2020 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045890
