UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005841 |
|---|---|
| Receipt number | R000006904 |
| Scientific Title | Identification of high-risk carotid plaque characteristics using in vivo 3T MR imaging. |
| Date of disclosure of the study information | 2011/06/24 |
| Last modified on | 2017/06/27 22:35:51 |
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Basic information
Public title
Identification of high-risk carotid plaque characteristics using in vivo 3T MR imaging.
Acronym
Identification of high-risk carotid plaque characteristics using in vivo 3T MR imaging.
Scientific Title
Identification of high-risk carotid plaque characteristics using in vivo 3T MR imaging.
Scientific Title:Acronym
Identification of high-risk carotid plaque characteristics using in vivo 3T MR imaging.
Region
| Japan |
Condition
Condition
Carotid artery stenosis
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to reveal high-risk carotid plaque characteristics for Japanese patients with carotid atherosclerotic disease using in vivo 3T MRI. First, we will compare carotid plaque characteristics between symptomatic and asymptomatic carotid stenosis. Second, we will follow up patients with asymptomatic carotid stenosis and examine the relationship between carotid plaque features and future celebrovascular ischemic events.
Basic objectives2
Others
Basic objectives -Others
Diagnosis of carotid disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare differences of carotid plaque features between symptomatic and asymptomatic carotid atherosclerosis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with more than 50% carotid stenosis as measured by ultrasound.
Key exclusion criteria
Patients with contraindication for MRI examination.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ota |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
1-1 Seiryo-machi, Aoba, Sendai, Miyagi, Japan
TEL
022-717-7312
h-ota@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ota |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
1-1 Seiryo Aoba Sendai
TEL
022-717-7312
Homepage URL
h-ota@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
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
Japan
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
| 2011 | Year | 06 | Month | 24 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
The purpose of this observational study was to evaluate carotid plaque characteristics using 3 Tesla MRI in Japanese population.
Management information
Registered date
| 2011 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006904
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
