UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013584 |
|---|---|
| Receipt number | R000015860 |
| Scientific Title | Computational Fluid Dynamics Analysis of Blood Flow in Cerebral Aneurysms: Prospective Observational Study |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2017/05/04 22:17:17 |
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Basic information
Public title
Computational Fluid Dynamics Analysis of Blood Flow in Cerebral Aneurysms: Prospective Observational Study
Acronym
CFD ABO Study
Scientific Title
Computational Fluid Dynamics Analysis of Blood Flow in Cerebral Aneurysms: Prospective Observational Study
Scientific Title:Acronym
CFD ABO Study
Region
| Japan |
Condition
Condition
unruptured cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prediction for the rupture of cerebral aneurysms is still difficult since we do not have enough information about the risk factors for the aneurysm rupture. We have suggested that arise in hemodynamic stress plays a central role in cerebral aneurysm formation due to asymmetric shape of the circle of Willis. In order to examine details of hemodynamics in human aneurysms and to clarify hemodynamic risk factors for rupture, enlargement and development of cerebral aneurysms, we start this multi-institutional prospective clinical study, using computational fluid dynamics (CFD) technique.
Basic objectives2
Others
Basic objectives -Others
To clarify whether hemodynamic related mediators can be risk factors for the rupture, enlargement, and development of cerebral aneurysms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distributions of hemodynamic factors, including normalized wall shear stress, wall shear stress gradient, oscillatory shear index, gradient oscillatory number, are evaluated among the ruptured aneurysm group, the enlarged aneurysm group, and the non-ruptured & non-enlarged aneurysm group.
Key secondary outcomes
1. In order to clarify the effect of hemodynamic factors on aneurysm growth, we virtually reconstruct arterial geometry of human cerebral aneurysms just before the development of aneurysms by artificial removal of the aneurysm, and compare values of hemodynamic factors between aneurysm-developed side and non-developed normal side.
2. Modified Rankin Scales are evaluated between the surgical group and the non-surgical group.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
unruptured saccular cerebral aneurysms more than 2mm
Key exclusion criteria
dissecting cerebral aneurysm
bacterial cerebral aneurysm
cerebral aneurysm treated with clipping surgery and/or coil embolization
the case that examinations of contrast radiography are not possible due to any reason, such as contrast media allergy, renal impairment, and/or pregnancy
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Fukuda |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Neurosurgery
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto City, Kyoto, Japan
TEL
075-641-9161
sfukuda@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichi Fukuda |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Neurosurgery
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto City, Kyoto, Japan
TEL
075-641-9161
Homepage URL
sfukuda@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
Address
Tel
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
| 2014 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational prospective study (registered period: 2 years, observation period: 3 years)
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2017 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015860
