UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034292 |
|---|---|
| Receipt number | R000039095 |
| Scientific Title | Study on change of connectivity and the brain structure in the lacunar infarction patients |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2018/09/27 14:52:50 |
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Basic information
Public title
Study on change of connectivity and the brain structure in the lacunar infarction patients
Acronym
Study on change of connectivity and the brain structure in the lacunar infarction patients
Scientific Title
Study on change of connectivity and the brain structure in the lacunar infarction patients
Scientific Title:Acronym
Study on change of connectivity and the brain structure in the lacunar infarction patients
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In lacunar infarction patients, We compare the changes in body function, cognitive function, brain structure using MRI.
Basic objectives2
Others
Basic objectives -Others
We investigate the association of each data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of the brain structure of various MRI
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Initial attack of stroke
(2)Infarction in the territory of the perforating arteries of the MCA, which should be defined by MR DW image.
(3)Informed consent
Key exclusion criteria
(1) Severe past history of brain, psychologycal disease
(2) Metalic implant (pace maker, coronaly stent, artificial joint, etc.)
(3) Claustrophobia
(4) Do not (cannot) concent to this study
(5) Who assessed as not suitable for this study by conducting doctors
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taki Yasuyuki |
Organization
IDAC, Tohoku University
Division name
Depertment of nuclear medicine and Radiology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutoh Tatsushi |
Organization
IDAC, Tohoku University
Division name
Depertment of nuclear medicine and Radiology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL
022-717-8559
Homepage URL
tmutoh@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
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
| 2018 | Year | 09 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039095
