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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014415
Receipt No. R000016770
Scientific Title Analysis of carotid blood parameters during the carotid artery stenting
Date of disclosure of the study information 2014/07/01
Last modified on 2014/06/29

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Basic information
Public title Analysis of carotid blood parameters during the carotid artery stenting
Acronym Analysis of carotid blood parameter during CAS
Scientific Title Analysis of carotid blood parameters during the carotid artery stenting
Scientific Title:Acronym Analysis of carotid blood parameter during CAS
Region
Japan

Condition
Condition Carotid artery stenosis
Classification by specialty
Cardiology Neurology Vascular surgery
Neurosurgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Less invasive carotid artery stenting (CAS) have been done for treatment of carotid stenosis. But the dynamic changes of carotid artery blood parameters are not clearly analyzed. Evaluations of blood parameter changes make the breakthrough of treatment strategy of CAS.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of local blood parameters. Cerebral ischemic lesion at day 1.
Hyperperfusion syndrome or phenomenon.
Re-stenosis of carotid artery after 12 months.
Key secondary outcomes Other complications

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Atherosclerotic carotid artery stenosis
Key exclusion criteria Non-atherosclerotic carotid artery stenosis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihito Shimamura
Organization Hirosaki University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 5-Zaihuchou, Hirosaki, Aomori pref.
TEL 0172-39-5115
Email shimab@cc.hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihito Shimamura
Organization Hirosaki University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 5-Zaihuchou, Hirosaki, Aomori pref.
TEL 0172-39-5115
Homepage URL
Email shimab@cc.hirosaki-u.ac.jp

Sponsor
Institute Department of Neurosurgery
Hirosaki University School of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery
Hirosaki University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 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 06 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 07 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyze blood samples 4 times, and analysis contents are free radicals, c-AMP, acidic LDL and so on. Blood sampling will be done after the insertion of sheath, before stenting, after the post stenting balloon angioplasty and before removal of sheath.
Neurological examination and brain MRI will be done before and next day of the CAS. We will evaluate neurological findings and brain MRI after 6 months, 12 months, and 24 months after the CAS.

Management information
Registered date
2014 Year 06 Month 29 Day
Last modified on
2014 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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