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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023264
Receipt No. R000026794
Scientific Title Detection of carotid artery plaque in the blood flow due to new ultrasonic inspection method that does not use a contrast agent
Date of disclosure of the study information 2016/07/21
Last modified on 2016/07/21

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Basic information
Public title Detection of carotid artery plaque in the blood flow due to new ultrasonic inspection method that does not use a contrast agent
Acronym Blood flow in the carotid artery plaque
Scientific Title Detection of carotid artery plaque in the blood flow due to new ultrasonic inspection method that does not use a contrast agent
Scientific Title:Acronym Blood flow in the carotid artery plaque
Region
Japan

Condition
Condition Carotid atherosclerosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients with blood flow signal into the plaque at the time of non contrast enhanced in the carotid echo test, blood flow signal seen in the non contrast enhanced ultrasound underwent contrast enhanced ultrasonography is consider really whether the blood flow in the plaque.
Evaluate the correlation between the contrast and non contrast, to consider whether the non contrast enhanced ultrasonic plaques in the blood flow in the test can be visualized. In addition, also examined tissue characteristics of the part to recognize the carotid plaque tissue characterization diagnostic software iPlaque and plaque in the blood flow.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes indicator of the carotid artery echocardiography
plaque size, plaque brightness, plaque surface, blood flow degree, functional assessment items that are recommended in the guidelines, such as stenosis rate.
contrast-enhanced ultrasonography
assess the presence or absence of plaque in the blood flow signals in the contrast-enhanced ultrasonography.
iPlaque
tissue characterization evaluation of carotid artery plaque.
CEA specimen
compare the plaque within the blood flow at the resected specimen and each technique.
Key secondary outcomes Patients Background and history
medical record ID, age, sex, body weight, the presence or absence of complications, history of allergy, history
Cardiovascular disease
valvular disease, cardiomyopathy, ischemic heart disease, arteriosclerosis obliterans, vasculitis, other
Cardiovascular factors
high blood pressure, diabetes, dyslipidemia, taste history
oral medicine
ACE, ARB, CCB, B-blocker, diuretics, statins, other.
clinical examination blood count
the number of white blood cells, red blood cell count, hemoglobin, platelet count, etc.
Biochemistry
hepatobiliary system, kidney, function indicator of the pancreas

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 When admitted the blood flow in the plaque in the present study in the carotid artery echo test, the Perufurubutan 0.015ml / kg administered bolus, to record the same plaque in contrast harmonic mode. The subject provides information by using the use attachments of Perufurubutan, describes the effect of adverse events and side effects. 30 minutes after the contrast agent used to confirm the vital, to observe that there is no appearance of symptoms.
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 Tokushima University Hospital in an enforcement plan to carotid endarterectomy, and patient consent was obtained for registration to the study at the time of carotid artery echocardiography.
Key exclusion criteria Not obtained consent to the person or persons Daidaku
Contraindication cases of contrast-enhanced ultrasonography enforcement (patient patient with a history of hypersensitivity to components of this drug, to eggs or egg products are allergic)
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu Yamada
Organization Tokushima University Hospital
Division name Department of Cardiovascular internal medicine
Zip code
Address 2-50-1, kumamoto, tokushima city, tokushima
TEL 088-633-7851
Email yamadah@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Yamada
Organization Tokushima University Hospital
Division name Department of Cardiovascular internal medicine
Zip code
Address 2-50-1, kumamoto, tokushima city, tokushima
TEL 088-633-7851
Homepage URL
Email yamadah@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima University
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 21 Day
Last modified on
2016 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026794

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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