UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023264 |
|---|---|
| Receipt number | 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 09:04:30 |
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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
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
yamadah@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026794
