UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024904
Receipt number 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 15:00:26

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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 or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



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

Value
https://center6.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