UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024600 |
|---|---|
| Receipt number | R000028308 |
| Scientific Title | Impact of heterogeneity of human peripheral blood monocyte subsets on brain salvage in patients with stroke |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2016/10/27 20:16:43 |
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Basic information
Public title
Impact of heterogeneity of human peripheral blood monocyte subsets on brain salvage in patients with stroke
Acronym
Stroke and monocyte subsets
Scientific Title
Impact of heterogeneity of human peripheral blood monocyte subsets on brain salvage in patients with stroke
Scientific Title:Acronym
Stroke and monocyte subsets
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association between acute brain salvage and peripheral monocyte subsets.
Basic objectives2
Others
Basic objectives -Others
NIHSS score at 6 month
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain salvage assessed by MRI at 14 days
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute stroke within 12 hours
Key exclusion criteria
Previous stroke
Contraindication of MRI
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akasaka Takashi |
Organization
Wakayama Medical University
Division name
Cardiovascular Medicine
Zip code
Address
811-1 Kimiider, Wakayama city
TEL
073-446-2300
t-nsgc@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nishiguchi Tsuyoshi |
Organization
Wakayama Medical University
Division name
Cardiovascular Medicine
Zip code
Address
811-1 Kimiidera, Wakayama city
TEL
073-446-2300
Homepage URL
t-nsgc@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical 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
| 2016 | Year | 11 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
50 patients were enrolled
Management information
Registered date
| 2016 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028308
