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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024600
Receipt No. 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

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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
Email 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
Email t-nsgc@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028308

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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