UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033598
Receipt number R000038296
Scientific Title 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 2022/08/04 13:56:13

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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


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

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 or person

Institute

Hirosaki University

Institute

Department

Personal name



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


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

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

Value
https://center6.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
Registered date File name