UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001232 |
|---|---|
| Receipt number | R000001502 |
| Scientific Title | A large prospective cohort study of cerebral microbleeds on MRI: prevalence, associations and a risk factor for stroke recurrence |
| Date of disclosure of the study information | 2008/07/07 |
| Last modified on | 2010/07/07 17:57:27 |
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Basic information
Public title
A large prospective cohort study of cerebral microbleeds on MRI: prevalence, associations and a risk factor for stroke recurrence
Acronym
MARS research (Microbleeds-Associated Recurrent Stroke research)
Scientific Title
A large prospective cohort study of cerebral microbleeds on MRI: prevalence, associations and a risk factor for stroke recurrence
Scientific Title:Acronym
MARS research (Microbleeds-Associated Recurrent Stroke research)
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Psychiatry | Radiology | Neurosurgery |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a multicenter, prospective cohort study to assess the potential role of cerebral microbleeds (MBs) detected by gradient-echo MRI in the stroke patients.
Assumptions and research questions are as followed.
1) MBs indicate a higher risk of future stroke, especially intracerebral hemorrhage.
2) Whether or not MBs increase intracerebral bleeding among patients on antithrombotic or anticoagulant treatment or those treated with thrombolysis for acute stroke.
3) To clarify the risk factors associated with MBs in stroke. Advanced age, chronic hypertension, hyperglycemia, and medication with antithrombotics or anticoagulants are a inducing factor but hyperlipidemia possibly inhibitive.
Basic objectives2
Others
Basic objectives -Others
A prospective cohort study determining MBs and their relation to recurrent stroke.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of stroke
Key secondary outcomes
Increment of the number of microbleeds
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Stroke patients with 50 years of age and older, developed during the period from July 2008 to June 2009.
2) Patients underwent gradient-echo T2*-weighted MR imaging.
Key exclusion criteria
Patients with intracerebral hematoma associated with ruptured cerbral aneurysm, arteriovenous malformation, moyamoya disease, brain tumor, and head trauma.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadahiro Otsuka |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Neurosurgery
Zip code
Address
1-5 Ninomaru, Kumamoto city, Kumamoto 860-0008, Japan
TEL
096-353-6501
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahiro Otsuka |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Neurosurgery
Zip code
Address
1-5 Ninomaru, Kumamoto city, Kumamoto 860-0008, Japan
TEL
096-353-6501
Homepage URL
otk@kumamoto2.hosp.go.jp
Sponsor or person
Institute
Department of Neurosurgery, National Hospital Organization Kumamoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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 | 07 | Day |
Related information
URL releasing protocol
http://www.csecr.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The patients registered have been followed for the reccurent stroke.
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
| 2008 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective cohort study
Management information
Registered date
| 2008 | Year | 07 | Month | 07 | Day |
Last modified on
| 2010 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001502
