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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024904
Receipt No. R000028654
Scientific Title Stroke recurrence using contrast enhanced ultrasonography(CEUS)
Date of disclosure of the study information 2016/11/18
Last modified on 2019/02/26

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Basic information
Public title Stroke recurrence using contrast enhanced ultrasonography(CEUS)
Acronym Stroke recurrence using contrast enhanced ultrasonography(CEUS)
Scientific Title Stroke recurrence using contrast enhanced ultrasonography(CEUS)
Scientific Title:Acronym Stroke recurrence using contrast enhanced ultrasonography(CEUS)
Region
Japan

Condition
Condition Carotid stenosis,Stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 plaque neovasculation by contrast-enhanced ultrasound.new surrogate marker?
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Contrast-enhanced ultrasound, Black-Blood MRI, Carotid ultrasound was associated stroke recurrence.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Carotid stenosis
Contrasted ultrasound
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Carotid stenosis
Stroke
Key exclusion criteria egg alergy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Uemura
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email uemuratrail@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Uemura
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email uemuratrail@yahoo.co.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
2016 Year 11 Month 18 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
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
2015 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 18 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028654

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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