UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of cerebral vasospasm evaluation method secondary to aneurysmal subarachnoid hemorrhage: cerebral circulation measurement by 3T MRI Arterial Spin Labeling
Acronym	Evaluation of cerebral vasospasm after aSAH by ASL
Scientific Title	Establishment of cerebral vasospasm evaluation method secondary to aneurysmal subarachnoid hemorrhage: cerebral circulation measurement by 3T MRI Arterial Spin Labeling
Scientific Title:Acronym	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
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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	1st name Hiroki Middle name Last name Ohkuma
Organization	Hirosaki University School of Medicine
Division name	Neurosurgery
Zip code	036-5302
Address	5-Zaihuchou, Hirosaki Aomori pref. JAPAN.
TEL	0172-39-5115
Email	ohkuma@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Naraoka
Organization	Hirosaki University School of Medicine
Division name	Neurosurgery
Zip code	036-5302
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)

IRB Contact (For public release)
Organization	Hirosaki University School of Medicine
Address	5-Zaihuchou, Hirosaki Aomori pref. JAPAN.
Tel	0172-39-5115
Email	nougeka@hirosaki-u.ac.jp

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	弘前大学医学部附属病院（青森県）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 01 Day

Related information
URL releasing protocol	http://www.med.hirosaki-u.ac.jp/~neuros/
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 30 Day
Date of IRB	2018 Year 05 Month 30 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 05 Month 31 Day

Other
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	2022 Year 08 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038296