UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of cerebrovascular reserve using 3D-ASL MRI
Title of the study (Brief title)	Measurement of cerebrovascular reserve using 3D-ASL MRI
Region	Japan

Condition
Condition	Obstructive cerebrovascular disease
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish the method for measurement of cerebrovascular reserve using 3D-ASL MRI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To optimize imaging parameters
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Intravenous infusion of acetazolamide 1000 mg
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adult Person without neuropsychiatric disorder Person without chronic disease
Key exclusion criteria	Pregnant woman, possible of pregnancy Contraindications for an MRI scan Contraindications for acetazolamide
Target sample size	8

Research contact person
Name of lead principal investigator	Toshimasa Hara
Organization	Kitasato University, School of Medicine
Division name	Department of Diagnostic Radiology
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
Email

Public contact
Name of contact person	Toshimasa Hara
Organization	Kitasato University, School of Medicine
Division name	Department of Diagnostic Radiology
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Kitasato University, School of Medicine
Institute
Department

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)

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	2013 Year 07 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 18 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ajnr.org/content/35/6/1111.full
Results
Other related information

Management information
Registered date	2013 Year 07 Month 10 Day
Last modified on	2017 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013074