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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000629
Receipt No. 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

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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
Email

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
Email hhoshino-keio@umin.ac.jp

Sponsor
Institute Keio University School of Medicine, Department of Neurology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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