UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000629 |
|---|---|
| Receipt number | R000000762 |
| Scientific Title | Study for early detection of progressing ischemic stroke of perforator arteries (SEPIA) |
| Date of disclosure of the study information | 2008/03/31 |
| Last modified on | 2011/10/04 14:59:17 |
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Basic information
Public title
Study for early detection of progressing ischemic stroke of perforator arteries (SEPIA)
Acronym
Study for early detection of progressing ischemic stroke of perforator arteries (SEPIA)
Scientific Title
Study for early detection of progressing ischemic stroke of perforator arteries (SEPIA)
Scientific Title:Acronym
Study for early detection of progressing ischemic stroke of perforator arteries (SEPIA)
Region
| Japan |
Condition
Condition
ischemic stroke (lacunar syndrome)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the methods of early detection of progressing perforator territory infarction
Basic objectives2
Others
Basic objectives -Others
To establish the methods of early detection of progressing perforator territory infarction
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
NIHSS, clinical backgrounds and blood clinical analysis within 14 days after the onset of ischemic stroke
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
1.Admission within 72 hours after the onset of ischemic stroke
2.Lacunar syndrome with motor weakness
Key exclusion criteria
1.consciouness disturbance and/or cortical signs
2.cortical infarction
3.heart disease that causes embolic stroke
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 165-8582 Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Hoshino |
Organization
Keio University School of Medicine
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 165-8582 Japan
TEL
03-3353-1211
Homepage URL
hhoshino-keio@umin.ac.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
Otsuka pharmaceutical Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Saiseikai Central Hospital
Name of secondary funder(s)
None
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
| 2008 | Year | 03 | Month | 31 | 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
| 2006 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
NIHSS, clinical backgrounds and blood clinical analysis within 14 days after the onset of ischemic stroke
Management information
Registered date
| 2007 | Year | 03 | Month | 05 | Day |
Last modified on
| 2011 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000762
