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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004869
Receipt No. R000005796
Scientific Title Study of imaging characteristics of arterial spin-labeling magnetic resonance imaging (ASL-MRI) in Brain stenoocclusive vascular disease
Date of disclosure of the study information 2011/01/13
Last modified on 2014/01/13

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Basic information
Public title Study of imaging characteristics of arterial spin-labeling magnetic resonance imaging (ASL-MRI) in Brain stenoocclusive vascular disease
Acronym ASL Imaging study
Scientific Title Study of imaging characteristics of arterial spin-labeling magnetic resonance imaging (ASL-MRI) in Brain stenoocclusive vascular disease
Scientific Title:Acronym ASL Imaging study
Region
Japan

Condition
Condition Patients with definite or probable brain stenoocclusive vascular disease
Classification by specialty
Neurology Vascular surgery Psychiatry
Oto-rhino-laryngology Radiology Neurosurgery
Laboratory medicine Rehabilitation medicine Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the imaging characteristics of ASL-MRI with variation of imaging parameters in normal and pathological states
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Comparative study between the imaging characteristics of ASL-MRI
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with definite or probable CVA
Key exclusion criteria Patients without IC
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki NOGUCHI
Organization Saga University
Division name Dept. of Radiology
Zip code
Address Saga City
TEL 0952-34-2309
Email tnogucci@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Noguchi
Organization Saga University
Division name Dept of Radiology
Zip code
Address 5-1-1, Nabeshima, Saga City, Saga Province, JAPAN
TEL 0952-34-2309
Homepage URL
Email tonoguti@cc.saga-u.au.jp

Sponsor
Institute Dept of Radiology, Saga University
Institute
Department

Funding Source
Organization Dept of Radiology, Saga University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2011 Year 01 Month 13 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 Enrolling by invitation
Date of protocol fixation
2010 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observation study

Management information
Registered date
2011 Year 01 Month 13 Day
Last modified on
2014 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005796

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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