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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001232
Receipt No. 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

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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
Email

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
Email otk@kumamoto2.hosp.go.jp

Sponsor
Institute Department of Neurosurgery, National Hospital Organization Kumamoto Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001502

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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