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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008661
Receipt No. 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

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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
Email

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
Email i-med2@med.hokudai.ac.jp

Sponsor
Institute Department of Medicine 2, Hokkaido University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010179

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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