UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001867 |
|---|---|
| Receipt number | R000002189 |
| Scientific Title | Change in cortical vein appearance on susceptibility-weighted MR imaging in chronic cerebral ischemia |
| Date of disclosure of the study information | 2009/04/10 |
| Last modified on | 2012/03/28 12:28:41 |
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Basic information
Public title
Change in cortical vein appearance on susceptibility-weighted MR imaging in chronic cerebral ischemia
Acronym
SWI in chronic ischemia
Scientific Title
Change in cortical vein appearance on susceptibility-weighted MR imaging in chronic cerebral ischemia
Scientific Title:Acronym
SWI in chronic ischemia
Region
| Japan |
Condition
Condition
Occlusion or stenosis of the Internal carotid artery
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to develop a simple method for evaluation of oxygen metabolism in chronic cerebral ischemia using MRI/SWI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cortical vein diameter or cortical intensity on SWI
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Internal carotid artery stenosis of 60% and more, or
internal carotid artery occlusion
Key exclusion criteria
severe disability
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Sorimachi |
Organization
Brain Research Institute, University of Niigata
Division name
Department of Neurosurgery
Zip code
Address
1-757, Asahimachidori, Chuoku, Niigata
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Brain Research Institute, University of Niigata
Division name
Department of Neurosurgery
Zip code
Address
TEL
Homepage URL
sorimachi@bri.niigata-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Brain Research Institute, University of Niigata
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Brain Research Institute, University of Niigata
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
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 10 | 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
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1, SWI is performed in patients with ICA stenosis or ICA occlusion.
2, SPECT is performed in the patients.
3, PET is performed if possible.
4, Comparison among the results of SWI, SPECT and PET to estimate a oxygen metabolic state in chronic ischemia.
Management information
Registered date
| 2009 | Year | 04 | Month | 10 | Day |
Last modified on
| 2012 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002189
