UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040241 |
|---|---|
| Receipt number | R000045872 |
| Scientific Title | Study of brain changes due to stress and remote brain check-up: deep subcortical white matter high intensity grade, periventricular hyperintensity grade, enlargement of Virchow-Robin space, age, gender, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, surgery history |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2020/04/26 16:33:10 |
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Basic information
Public title
Study of brain changes due to stress and remote brain check-up
Acronym
Study of brain changes due to stress and remote brain check-up
Scientific Title
Study of brain changes due to stress and remote brain check-up: deep subcortical white matter high intensity grade, periventricular hyperintensity grade, enlargement of Virchow-Robin space, age, gender, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, surgery history
Scientific Title:Acronym
Study of brain changes due to stress and remote brain check-up: deep subcortical white matter high intensity grade, periventricular hyperintensity grade, enlargement of Virchow-Robin space, age, gender, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, surgery history
Region
| Japan |
Condition
Condition
deep subcortical white matter high intensity, periventricular hyperintensity, enlargement of Virchow-Robin space
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the change deep subcortical white matter lesions, periventricular hyperintensity, and enlargement of Virchow-Robin space in healthy adults.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between deep subcortical white matter lesions, periventricular hyperintensity, enlargement of Virchow-Robin space and age, sex, BMI, hypertension, dyslipidemia, arrhythmia, stroke history, and surgical history.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
deep subcortical white matter high intensity grade periventricular hyperintensity, grade, enlargement of Virchow-Robin space grade
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal subjects undergoing brain check-up MRI
Key exclusion criteria
Cases without brain check-up MRI
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | FUSAO |
| Middle name | |
| Last name | IKAWA |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
693-8555
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
TEL
0853-22-5111
fikawa-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | FUSAO |
| Middle name | |
| Last name | IKAWA |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
693-8555
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
TEL
0853-22-5111
Homepage URL
fikawa-nsu@umin.ac.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane Prefectural Central Hospital
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
Shimane Prefectural Central Hospital, Clinical Research and Trial Management Center
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
Tel
0853-22-5111
chiken@spch.izumo.shimane.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 | 04 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | 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=R000045872
