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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024378
Receipt No. R000015691
Scientific Title Evaluation of carotid plaque using contrast enhanced ultrasonography
Date of disclosure of the study information 2016/10/12
Last modified on 2016/10/12

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Basic information
Public title Evaluation of carotid plaque using contrast enhanced ultrasonography
Acronym Evaluation of carotid plaque using CEUS
Scientific Title Evaluation of carotid plaque using contrast enhanced ultrasonography
Scientific Title:Acronym Evaluation of carotid plaque using CEUS
Region
Japan

Condition
Condition Ischemic stroke and transcient ischemic attack
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the usefulness of cotrast enhanced ultrasonographyon.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes modified Rankin scale on discharge
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 Maneuver
Interventions/Control_1 Purpose:
We performed CEUS in all patients and investigated the association between ultrasound imaging and patient characteristics, MRI findings and histpathological findings.

Patients charasteristics and MRI findigs:
1)age and sex,2) vascular risk factors including hypertension, diabetes mellitus, dyslipidemia and smoking, 3) laboratory parameters,4) the results of conventional carotid duplex sonography and CEUS before CEA,5) carotid plaque imaging on black-blood MRI (BB-MRI),6) the degree of internal carotid artery stenosis on conventional angiography and 7)histpathological findings.

Methods:
Contrast Enhanced Ultrasonography(CEUS):
A bolus intravenous injection of Sonazoid was performed via the peripheral venous line.
We preset the mechanical index to 0.18-0.20 and frame rate to 25 frames/sec.


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 Stroke and/or TIA patients 7days of onset admitted to our hospital
Key exclusion criteria allergy of Egg
severe lung disease
witten informed consent was not obtained
Other conditions judged ineligible by physician
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Matsumoto
Organization Kawasaki Medical Hospital
Division name Department od Stroke Medicine
Zip code
Address 577 Matsushima, Kurashiki Citym Okayama
TEL 086-462-1111
Email noripma@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Matsumoto
Organization Nippon Medical School
Division name Department of Neurology and Stroke Medicine
Zip code
Address 1-1-5 Sendagi, Bunkyou-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email n-matsumoto@nms.ac.jp

Sponsor
Institute Kawasaki Medical Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 川崎医科大学附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 12 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
2014 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 08 Day
Last follow-up date
2015 Year 03 Month 27 Day
Date of closure to data entry
2015 Year 03 Month 27 Day
Date trial data considered complete
2015 Year 03 Month 27 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 12 Day
Last modified on
2016 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015691

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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