UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014415 |
|---|---|
| Receipt number | 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 | 2020/04/27 15:46:27 |
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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 | Norihito |
| Middle name | |
| Last name | Shimamura |
Organization
Hirosaki University School of Medicine
Division name
Department of Neurosurgery
Zip code
036-8562
Address
5-Zaihuchou, Hirosaki, Aomori pref.
TEL
0172-39-5115
shimab@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Shimamura |
Organization
Hirosaki University School of Medicine
Division name
Department of Neurosurgery
Zip code
036-8562
Address
5-Zaihuchou, Hirosaki, Aomori pref.
TEL
0172-39-5115
Homepage URL
shimab@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery
Hirosaki University School of Medicine
Institute
Department
Personal name
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
Hirosaki University Ethics Committee
Address
5-Zaihuchou, Hirosaki Aomori pref. JAPAN.
Tel
0172-39-5295
cksenta@cc.hirosaki-u.ac.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
| 2014 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
doi:10.1136/neurintsurg-2017-013465
Publication of results
Partially published
Result
URL related to results and publications
doi:10.1136/neurintsurg-2017-013465
Number of participants that the trial has enrolled
22
Results
The dROM at sheath insertion correlated negatively with the dementia scale and positively with the DWI high spots.
Results date posted
| 2020 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-two consecutive CAS procedures were performed between May 2014 and April 2016.
Participant flow
N/A
Adverse events
No
Outcome measures
Arterial blood was collected four times. Derivatives of reactive oxygen metabolites and biological antioxidant potential were measured photometrically. The relationship between dROMs or BAP and preoperatively investigated biochemical parameters, cognitive function, and number of diffusion weighted image high spot lesions was analysed using one-way ANOVA and the Tukey Kramer HSD test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
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
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016770
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