UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001230 |
|---|---|
| Receipt number | R000001498 |
| Scientific Title | Secondary Prevention of Cerebral Infarction Epidemiological Study on Cerebral Microbleeds |
| Date of disclosure of the study information | 2008/07/02 |
| Last modified on | 2008/07/02 19:00:03 |
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Basic information
Public title
Secondary Prevention of Cerebral Infarction Epidemiological Study on Cerebral Microbleeds
Acronym
SCIENCE Study
Scientific Title
Secondary Prevention of Cerebral Infarction Epidemiological Study on Cerebral Microbleeds
Scientific Title:Acronym
SCIENCE Study
Region
| Japan |
Condition
Condition
cerebral infaction
Classification by specialty
| Neurology | Geriatrics | Radiology |
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of MR images in the secondary prevention of cerebral infarction
Basic objectives2
Others
Basic objectives -Others
cohort research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
symptomatic cerebral infarction and symptomatic cerebral hemorrhage
Key secondary outcomes
number of cerebral microbleeds, Grade of DWMH and PVH, ADL, event by antiplatelet drugs, symptom of upper GI and QOL, other cerebrovascular event, cardiovascular event, death
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
first onset symptomatic cerebral infarction
within 2 months after onset
primary treated by each hospital registered
MRI acceptable
mRS Grade0-4
3-year follow up executable
prior written informed consent
Key exclusion criteria
recurred symptomatic cerebral infarction
medicatin of antiplatelet drugs before onset
moyamoya disease, AVM, AN, dural AVF
previous cerebral contusion
previous craniotomy and/or burr hole surgery
future surgery and/or intervention for brain and heart
previous symptomatic cerebral hemorrhage, other hemorrhagic disease, coagulopathy
present malignancy
platelet count<10000/m3
liver dysfunction (AST>100IU/L, ALT>100IU/L)
renal dysfunction (Cre>3mg/dl)
future moving, diffculties for follow-up
amyloid angiopathy
participants in other intervening clinical research
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Hashimoto |
Organization
Graduate School of Medicine Kyoto University
(present National Cardiovascular Center)
Division name
Department of Neurosurgery
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
SCIENCE Study Group
Division name
SCIENCE Study office
Zip code
Address
TEL
Homepage URL
science@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
SCIENCE Study Protocol Comittee
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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 | 07 | Month | 02 | 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
Date of protocol fixation
| 2007 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
blood check, MRI, and recording of presence of any events for three years annually
Management information
Registered date
| 2008 | Year | 07 | Month | 02 | Day |
Last modified on
| 2008 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001498
