UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036929 |
|---|---|
| Receipt number | 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 | 2023/12/06 17:22:11 |
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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
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
smatsuo1979@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center Department of Neurosurgery
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000042080&flwp_key=1009qsZJQb0
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-19K18411/
Number of participants that the trial has enrolled
28
Results
The group with relatively high risk of rupture (other cerebral aneurysms: n=7) had a significantly larger change rate in neck diameter, neck diameter, maximal height, and cerebral aneurysm volume had bimodal peaks throughout the cardiac cycle.
Results date posted
| 2023 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients with unruptured and ruptured aneurysms who are clipped at our institute.
Participant flow
Electrocardiography gated CT Angiography is performed and the images are analyzed.
Adverse events
None
Outcome measures
The image processing was performed by dividing the single cardiac cycle (R-R interval) into 20 segments, creating 20 phases of maximum intensity projection and volume rendering images per cerebral aneurysm, and measuring the morphology of each cerebral aneurysm.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 22 | Day |
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
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042080
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