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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022057
Receipt No. R000025420
Scientific Title Novel approach for elucidating pathophysiology in patients with acute lacuna stroke
Date of disclosure of the study information 2019/03/31
Last modified on 2019/04/29

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Basic information
Public title Novel approach for elucidating pathophysiology in
patients with acute lacuna stroke
Acronym Novel approach for elucidating pathophysiology in
patients with acute lacuna stroke
Scientific Title Novel approach for elucidating pathophysiology in
patients with acute lacuna stroke
Scientific Title:Acronym Novel approach for elucidating pathophysiology in
patients with acute lacuna stroke
Region
Japan

Condition
Condition acute lacuna stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the changes in cerebral blood flow, metabolism, and injury of neuronal fiber after the onset of lacuna
stroke until 3 or 6 months after the onset.
Basic objectives2 Others
Basic objectives -Others To clarify the effect of acute rehabilitation after
the onset of lacuna stroke until 3 months on
cerebral blood flow, metabolism, and injury of neuronal
fiber.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between cerebral blood flow and metabolism by positron emission tomography and parameters of tractgraphy by diffusion tensor imaging at the 2 points, such
as 10 days and 3-6 months after the stroke onset.
Key secondary outcomes Changes of the levels of serum biomarker, such as
D-dimer,fibrinogen,thrombin antithrombin
complex, soluble intercellular adhesion molecule-1,
interlukin-6, and tumor necrosis factor.

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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Within 48 hours after the stroke onset.
Premorbid mRS is 2 or below 2.
Lacuna patients whose responsible lesion is perforator
areas diagnosed by MRI.
Key exclusion criteria Stroke patients whose responsible lesions were brainstem or cerebellar.
Patients who cannot be undergone examination of
MRI.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Chiaki
Middle name
Last name Yokota
Organization National Cerebral and Cardiovascular Center
Division name Cerebrovascular Rehabilitation
Zip code 565-8565
Address 5-7-1, Fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Email cyokota@ncvc.go.jp

Public contact
Name of contact person
1st name Chiaki
Middle name
Last name Yokota
Organization National Cerebral and Cardiovascular Center
Division name Cerebrovascular Rehabilitation
Zip code 565-8565
Address 5-7-1, Fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email cyokota@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization JSPS KAKENHI 16K10747
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cerebral and Caerdiovascular Center
Address 5-7-1, Fujishirodai, Suita, Osaka, Japan
Tel 06-6833-5012
Email cyokota@ncvc.go.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
2019 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 16
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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 25 Day
Date of IRB
2016 Year 02 Month 29 Day
Anticipated trial start date
2016 Year 04 Month 25 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Changes of neuronal severity evaluated by NIHSS and
cognitive function will be also examined during
observational period.

Management information
Registered date
2016 Year 04 Month 25 Day
Last modified on
2019 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025420

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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