UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042113 |
|---|---|
| Receipt number | R000048058 |
| Scientific Title | Clinical research on hemodynamic predictors for the progression of major intracranial cerebrovascular stenosis using CFD analysis |
| Date of disclosure of the study information | 2020/10/14 |
| Last modified on | 2020/10/14 20:31:13 |
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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
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
fukudashunichi@gmail.com
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
National Hospital Organization
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048058
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
