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

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 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


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

Value
https://center6.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