UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024378
Receipt number 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 19:18:53

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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 or person

Institute

Kawasaki Medical Hospital

Institute

Department

Personal name



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

Value
https://center6.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