UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research on hemodynamic predictors for the progression of major intracranial cerebrovascular stenosis using CFD analysis
Acronym	CV Stenosis CFD Study
Scientific Title	Clinical research on hemodynamic predictors for the progression of major intracranial cerebrovascular stenosis using CFD analysis
Scientific Title:Acronym	CV Stenosis CFD Study
Region	Japan

Condition
Condition	major intracranial artery stenosis
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Major intracranial artery stenosis, such as intracranial internal carotid artery, middle cerebral artery M1 portion, anterior cerebral artery A1 portion, intracranial vertebral artery, and basilar artery, is major cause of atherosclerotic cerebral infarction. However, we cannot sufficiently predict the progression of stenosis followed by symptomatic stroke using known risk factors. Our previous NHO collaborative clinical study suggested that hemodynamic factors may be significantly involved in the development of cerebral infarction due to carotid artery stenosis. Therefore, the hemodynamics may also be involved in intracranial artery stenosis. In this study, we would like to elucidate the hemodynamic etiology of major intracranial artery stenosis using computational fluid dynamics (CFD) analysis and search for new predictors of the stenosis progression.
Basic objectives2	Others
Basic objectives -Others	Search for hemodynamic risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify hemodynamic factors that are significantly involved in the progression of major intracranial artery stenosis using computational fluid dynamics (CFD) analysis.
Key secondary outcomes	To identify hemodynamic factors that are significantly involved in the development of symptomatic cerebral infarction due to major intracranial artery stenosis using CFD analysis.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Cases who have undergone cerebrovascular 3D contrast-enhanced CT examination or 3D cerebral angiography examination for which the original image DICOM data remain 2) Cases with about 30% or more stenosis found in the intracranial main artery (intracranial internal carotid artery, middle cerebral artery M1 portion, anterior cerebral artery A1 portion, intracranial vertebral artery, and basilar artery) by cerebrovascular imaging 3) Cases aged 20 years or older at the time of consent acquisition 4) Cases who have obtained the voluntary written consent of the patient (or his / her substitute)
Key exclusion criteria	1) Cases with stenosis after irradiation 2) Cases with moyamoya disease 3) Cases with stenosis due to dissection 4) Cases with congenital stenosis 5) Cases after bypass surgery on the diseased side (registration is possible if there is an unoperated stenotic lesion on the contralateral side) 6) Patients after angioplasty of the lesion (registration is possible if there are other unoperated stenotic lesions) 7) When the principal investigator and the research coordinator judge that participation in this research is not appropriate
Target sample size	650

Research contact person
Name of lead principal investigator	1st name Shunichi Middle name Last name Fukuda
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Neurosurgery
Zip code	612-8555
Address	1-1, Mukaihara-cho, Fukakusa, Fushimi-ku, Kyoto City
TEL	075-641-9161
Email	fukudashunichi@gmail.com

Public contact
Name of contact person	1st name Shunichi Middle name Last name Fukuda
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Neurosurgery
Zip code	612-8555
Address	1-1, Mukaihara-cho, Fukakusa, Fushimi-ku, Kyoto City
TEL	075-641-9161
Homepage URL
Email	fukudashunichi@gmail.com

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)

IRB Contact (For public release)
Organization	National Hospital Organization
Address	2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel	03-5712-5050
Email	700-kenkyu@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	2020 Year 10 Month 14 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	2020 Year 09 Month 23 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 15 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	At the time of registration: Patient background, 3D cerebrovascular examination (3D contrast CT, 3D cerebrovascular imaging) Two years after the registration: Cerebrovascular imaging

Management information
Registered date	2020 Year 10 Month 14 Day
Last modified on	2020 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048058