UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022057 |
|---|---|
| Receipt number | 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 | 2021/10/29 10:48:13 |
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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.
Analysis of Neurite orientation dispersion and density imaging (baseline, 3 months)
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
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
cyokota@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025420
