UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020045 |
|---|---|
| Receipt number | R000023149 |
| Scientific Title | A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis. |
| Date of disclosure of the study information | 2015/12/04 |
| Last modified on | 2018/02/14 11:22:05 |
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Basic information
Public title
A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.
Acronym
A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.
Scientific Title
A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.
Scientific Title:Acronym
A prospective study for impact of the carotid artery stenting on cognitive function in patients with extracranial carotid artery stenosis.
Region
| Japan |
Condition
Condition
Extracranial carotid artery stenosis
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In some cases, cognitive function improves after carotid artery stenting in patients with carotid artery stenosis. The aim of this study is to figure out predictors of postoperative cognitive function from preoperative functional connectivity analysis of the brain network and regional cerebral blood flow study.
Basic objectives2
Others
Basic objectives -Others
Basic objectives are to understand the mechanisms of the of cognitive function improvement following carotid artery stenting, and to establish biomarkers which can predict the cognitive function after carotid artery stenting based on preoperative functional connectivity analysis of brain network and regional cerebral blood flow study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of cognitive function after carotid artery stenting
Key secondary outcomes
1)Alteration of functional connectivity
2)Alteration of regional cerebral blood flow
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are scheduled for carotid artery stenting
2) Patients who have agreed to participate in this study with an informed consent.
Key exclusion criteria
1) Patients judged not to be eligible by the primary doctor
2) Any other disease which can affect patient's cognitive function
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Tani |
Organization
Osaka General Medical Center
Division name
Department of Neurosurgery
Zip code
Address
Sumiyoshi-ku Mandai Higashi 3-1-56, Osaka city, Osaka, Japan
TEL
06-6692-1201
n-tani@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Tani |
Organization
Osaka General Medical Center
Division name
Department of Neurosurgery
Zip code
Address
Sumiyoshi-ku Mandai Higashi 3-1-56, Osaka city, Osaka, Japan
TEL
06-6692-1201
Homepage URL
n-tani@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Mitsui Life Social Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hanwa Memorial Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪府立急性期総合医療センター （大阪府）、阪和記念病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 04 | 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
Post-CAS cognitive function varied between patients and between categories of neuropsychological tests. Although there was no significant overall improvement in working memory scores after CAS, post-CAS working memory scores changed in negative correlation with changes in FC of the DMN between the precentral/superior frontal gyrus and middle frontal gyrus. In addition, FC of the DMN between the preoperative precentral/superior frontal gyrus and medial frontal gyrus correlated positively with the post-CAS improvement in working memory.
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
| 2015 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 14 | Day |
Other
Other related information
This is a prospective cohort study. Participants have already been indicated for carotid artery stenting (CAS) in Osaka General Medical Center or Hanwa Memorial Hospital independently of this study from December 2015 to March 2017 (all participants will receive standard CAS in clinical settings provided by their attending neurosurgeons. The informed consent for CAS have already been obtained before recruitment independently of the study).
Participants are required to meet the inclusion criteria (1.Patients that are scheduled for carotid artery stenting. 2.The patients who have agreed to participate in this study with an informed consent.) and are required not to meet the exclusion criteria (1. Patients judged not to be eligible by the principal investigator. 2.Any other disease that can affect patient's cognitive function.)
Participants will undergo cognitive assessment (WMS-R, WAIS-III), MRI and cerebral blood flow assessment (SPECT) before and after CAS.
For control group, we will include age- and gender-matched healthy controls.
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023149
