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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036929
Receipt No. R000042080
Scientific Title Computational fluid dynamics analysis of blood flow in cerebral aneurysms considering the pulsation of the aneurysm wall.
Date of disclosure of the study information 2019/06/03
Last modified on 2019/06/03

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Basic information
Public title Computational fluid dynamics analysis of blood flow in cerebral aneurysms considering the pulsation of the aneurysm wall.
Acronym Computational fluid dynamics analysis of blood flow in cerebral aneurysms considering the pulsation of the aneurysm wall.
Scientific Title Computational fluid dynamics analysis of blood flow in cerebral aneurysms considering the pulsation of the aneurysm wall.
Scientific Title:Acronym Computational fluid dynamics analysis of blood flow in cerebral aneurysms considering the pulsation of the aneurysm wall.
Region
Japan

Condition
Condition Cerebral aneurysm
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine details of hemodynamics in human aneurysms to clarify hemodynamic factors for risk factors for rupture and enlargement and development of the unruptured aneurysm by analyzing 4D-CT angiography with CFD technique. In addition, this study also aims to examine the hemodynamic factors for prediction of the rupture point.
Basic objectives2 Others
Basic objectives -Others To clarify whether the rupture point can be predicted by using CFD analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To examine the distribution of the hemodynamic factors among the non-enlarged aneurysm group, enlarged aneurysm group, and ruptured aneurysm group.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 4D-CT angiography
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 The patients with unruptured and ruptured aneurysms who are clipped at our institute.
Key exclusion criteria The patients who had arrhythmia or renal failure.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Nakamizo
Organization National Hospital Organization Kyushu Medical Center
Division name Neurosurgery
Zip code 810-8563
Address 1-8-1, Jigyo-hama, Chuouku, Fukuoka, Japan
TEL 092-852-0700
Email nakamizo@ns.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Matsuo
Organization National Hospital Organization Kyushu Medical Center
Division name Neurosurgery
Zip code 810-8563
Address 1-8-1, Jigyo-hama, Chuouku, Fukuoka, Japan
TEL 092-852-0700
Homepage URL
Email smatsuo1979@gmail.com

Sponsor
Institute National Hospital Organization Kyushu Medical Center Department of Neurosurgery
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Kyushu Medical Center
Address 1-8-1, Jigyo-hama, Chuouku, Fukuoka, Japan
Tel 092-852-0700
Email 602-rinri@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 03 Day

Related information
URL releasing protocol
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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042080

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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