UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of carotid plaque using contrast enhanced ultrasonography
Title of the study (Brief title)	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	Noriko Matsumoto
Organization	Kawasaki Medical Hospital
Division name	Department od Stroke Medicine
Address	577 Matsushima, Kurashiki Citym Okayama
TEL	086-462-1111
Email	noripma@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Noriko Matsumoto
Organization	Nippon Medical School
Division name	Department of Neurology and Stroke Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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