UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025903 |
|---|---|
| Receipt number | R000029770 |
| Scientific Title | The prospective observational study using computational fluid dynamic analyses for a role of hemodynamic stress in carotid artery stenosis progression |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2017/01/30 14:24:00 |
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Basic information
Public title
The prospective observational study using computational fluid dynamic analyses for a role of hemodynamic stress in carotid artery stenosis progression
Acronym
The prospective observational study using computational fluid dynamic analyses for a role of hemodynamic stress in carotid artery stenosis progression (CFD CAP study)
Scientific Title
The prospective observational study using computational fluid dynamic analyses for a role of hemodynamic stress in carotid artery stenosis progression
Scientific Title:Acronym
The prospective observational study using computational fluid dynamic analyses for a role of hemodynamic stress in carotid artery stenosis progression (CFD CAP study)
Region
| Japan |
Condition
Condition
cervical carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarification of hemodynamic risk factors for carotid artery stenosis using computational fluid dynamics analysis
Basic objectives2
Others
Basic objectives -Others
elucidation of risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemodynamic risk factors for progression of carotid artery stenosis
Key secondary outcomes
hemodynamic risk factors for restenosis after carotid endarterectomy, restenosis after carotid artery stenting,symptomatic carotid artery stenosis, characteristics of plaque, and plaque destabilisation
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 in which 3DCT angiography examination or 3D cerebral angiography examination was performed
2. Cases of carotid artery stenosis with a stenosis rate of 50% or more in carotid echocardiography
3. Cases in which document consent was obtained by principal or substitute person
Key exclusion criteria
1. Carotid stenosis after irradiation
2. Carotid stenosis due to aortitis
3. Carotid stenosis due to fibromuscular dysplasia
4. Carotid stenosis due to dissection
5. Congenital carotid stenosis
6. Carotid stenosis after carotid endarterectomy or carotid artery stenting
7. Case in which 3D contrast enhanced imaging can not be performed due to contrast ant allergy or renal dysfunction
8. Cases judged that participation in this study is not appropriate by attending physician
Target sample size
850
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 f Neurosurgery
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto City, Kyoto, Japan
TEL
+81-75-641-9161
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 f Neurosurgery
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto City, Kyoto, Japan
TEL
+81-75-641-9161
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
Japanese Governmental office
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
| 2017 | Year | 01 | Month | 31 | 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
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | 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
We will examine differences in hemodynamic distributions between the advanced group in which stenosis rate progressed by 10% or more and non-advanced group during 2-year observation period
Management information
Registered date
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029770
| 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 |
