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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033598
Receipt No. R000038296
Official scientific title of the study Establishment of cerebral vasospasm evaluation method secondary to aneurysmal subarachnoid hemorrhage: cerebral circulation measurement by 3T MRI Arterial Spin Labeling
Date of disclosure of the study information 2018/08/01
Last modified on 2018/08/01

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Basic information
Official scientific title of the study
Establishment of cerebral vasospasm evaluation method secondary to aneurysmal subarachnoid hemorrhage: cerebral circulation measurement by 3T MRI Arterial Spin Labeling
Title of the study (Brief title)
Evaluation of cerebral vasospasm after aSAH by ASL
Region
Japan

Condition
Condition Cerebral vasospasm after aneurysmal subarachnoid hemorrhage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Cerebral vasospasm occurring from 4th to 14th day after the onset of subarachnoid hemorrhage is the most serious complication that affects the outcome after subarachnoid hemorrhage. Evaluation of cerebrovascular and circulatory dynamics is extremely important for early detection of cerebral ischemia / neurological symptoms associated with cerebral vasospasm, but cerebrovascular imaging as a golden standard and SPECT are invasive and can not escape radiation exposure . Therefore, we aim to establish a non-invasive and convenient detection and diagnosis method of cerebral vasospasm by arterial spin labeling (ASL) method.
Basic objectives2 Others
Basic objectives -Others Evaluation of cerebral vasospasm after SAH by ASL
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Symptomatic cerebral vasospasm and prognosis
Key secondary outcomes Angiographic vasospasm

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria aneurysmal Subarachnoid hemorrhage
Unruptured cerebral aneurysm
Key exclusion criteria none
Target sample size 40

Research contact person
Name of lead principal investigator Hiroki Ohkuma
Organization Hirosaki University School of Medicine
Division name Neurosurgery
Address 5-Zaihuchou, Hirosaki Aomori pref. JAPAN.
TEL 0172-39-5115
Email ohkuma@hirosaki-u.ac.jp

Public contact
Name of contact person Masato Naraoka
Organization Hirosaki University School of Medicine
Division name Neurosurgery
Address 5-Zaihuchou, Hirosaki Aomori pref. JAPAN.
TEL 0172-39-5115
Homepage URL
Email nessun@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2018 Year 08 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 30 Day
Anticipated trial start date
2018 Year 08 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 http://www.med.hirosaki-u.ac.jp/~neuros/
Publication of results Unpublished
URL releasing results
Results
Other related information We evaluate cerebral vasospasm after aneurysmal SAH and unruptured cerebral aneurysm cases treated according to aSAH . Cerebrovascular imaging, MRI arterial spin labeling (ASL), cerebral blood flow single photon emission CT (SPECT) are essential items to be analyzed and cerebral blood flow analysis during cerebral vasospasm is aimed.

Management information
Registered date
2018 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038296

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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