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
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
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
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
