UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of carotid artery plaque in the blood flow due to new ultrasonic inspection method that does not use a contrast agent
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hirotsugu Yamada
Organization	Tokushima University Hospital
Division name	Department of Cardiovascular internal medicine
Address	2-50-1, kumamoto, tokushima city, tokushima
TEL	088-633-7851
Email	yamadah@tokushima-u.ac.jp

Public contact
Name of contact person	Hirotsugu Yamada
Organization	Tokushima University Hospital
Division name	Department of Cardiovascular internal medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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