UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008661 |
|---|---|
| Receipt number | R000010179 |
| Scientific Title | Research for the molecular clarification and control in the progression of atherosclerosis using the plaque after carotid endarterectomy |
| Date of disclosure of the study information | 2012/08/09 |
| Last modified on | 2012/08/09 20:14:05 |
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Basic information
Public title
Research for the molecular clarification and control in the progression of atherosclerosis using the plaque after carotid endarterectomy
Acronym
Research for the molecular clarification and control in the progression of atherosclerosis using the plaque after carotid endarterectomy
Scientific Title
Research for the molecular clarification and control in the progression of atherosclerosis using the plaque after carotid endarterectomy
Scientific Title:Acronym
Research for the molecular clarification and control in the progression of atherosclerosis using the plaque after carotid endarterectomy
Region
| Japan |
Condition
Condition
Atherosclerosis in carotid artery
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pathogenesis and mechanism, which make the development of Atherosclerosis and rupture of the plaque in the carotid plaque, and to reveal the existence and expression of atherosclerotic related proteins.
Basic objectives2
Others
Basic objectives -Others
Examination of the association between macrophage phenotype and plaque vulnerability and clinical events
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression of inflammatory macrophages and atherosclerotic related proteins and cytokines with the plaque after carotid endarterectomy.
Ultrasound determination of carotid stenosis and plaque vulnerability
Key secondary outcomes
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
Patients who are scheduled to carotid endarterectomy
Key exclusion criteria
Patients who have been judged unsuitable as subjects by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Medicine 2
Zip code
Address
N14, W5, kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
81-11-706-5915
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Medicine 2
Zip code
Address
N14, W5, kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
81-11-706-5915
Homepage URL
i-med2@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Medicine 2, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine 2, Hokkaido University Hospital
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
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
北海道大学病院（北海道）、札幌麻生脳神経外科病院（北海道）、中村記念病院（北海道）、市立札幌病院脳神経外科（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Pro-inflammatory macrophage content of atherosclerotic plaques is associated with clinical incidence of ischemic stroke, and increased inflammation or fibrinogenolysis. Furthermore, we show the benefits of using ultrasound to predict vulnerability in the carotid artery plaque.
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
Completed
Date of protocol fixation
| 2008 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pro-inflammatory macrophage content of atherosclerotic plaques is associated with clinical incidence of ischemic stroke, and increased inflammation or fibrinogenolysis. Furthermore, we show the benefits of using ultrasound to predict vulnerability in the carotid artery plaque.
Management information
Registered date
| 2012 | Year | 08 | Month | 09 | Day |
Last modified on
| 2012 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010179
