UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Computational Fluid Dynamics Analysis of Blood Flow in Cerebral Aneurysms: Prospective Observational Study
Title of the study (Brief title)	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	Shunichi Fukuda
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Neurosurgery
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto City, Kyoto, Japan
TEL	075-641-9161
Email	sfukuda@kyotolan.hosp.go.jp

Public contact
Name of contact person	Shunichi Fukuda
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Neurosurgery
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto City, Kyoto, Japan
TEL	075-641-9161
Homepage URL
Email	sfukuda@kyotolan.hosp.go.jp

Sponsor
Institute	National Hospital Organization
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 02 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015860