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Recruitment status
Unique ID issued by UMIN UMIN000025902
Receipt No. R000029526
Scientific Title Association between the presence of intraplaque hemorrhage and prior stroke in the patients with low grade carotid artery stenosis.
Date of disclosure of the study information 2017/01/30
Last modified on 2017/01/30

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Basic information
Public title Association between the presence of intraplaque hemorrhage and prior stroke in the patients with low grade carotid artery stenosis.
Acronym Carotid intraplaque hemorrhage and prior stroke of low grade carotid artery stenosis
Scientific Title Association between the presence of intraplaque hemorrhage and prior stroke in the patients with low grade carotid artery stenosis.
Scientific Title:Acronym Carotid intraplaque hemorrhage and prior stroke of low grade carotid artery stenosis
Region
Japan

Condition
Condition carotid artery stenosis
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Carotid artery stenosis is one of the important causes of stroke. Degree of stenosis is the risk factor of it. However, low grade stenosis often causes stroke.
Carotid intraplaque hemorrhage
The purpose of this study is to elucidate whether
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prior stroke caused by low grade carotid artery stenosis
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Low grade carotid artery stenosis
Key exclusion criteria patients who cannot receive MRI
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyofumi Yamada
Organization Sato Daichi Hospital
Division name Neurosurgery
Zip code
Address 1-1, Hokyoji, Usa, Oita
TEL 0978322110
Email yamadakiyofumi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kiyofumi Yamada
Organization Hyogo College of Medicine
Division name Neurosurgery
Zip code
Address 1-1, Mukogawa cho, Nishinomiya, Hyogo
TEL 0798456455
Homepage URL
Email yamadakiyofumi@gmail.com

Sponsor
Institute Sato Daichi Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Other
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
2017 Year 01 Month 30 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
Date of protocol fixation
2016 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2017 Year 01 Month 30 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029526

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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