UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009205 |
|---|---|
| Receipt number | R000010807 |
| Scientific Title | Magnetic Resonance plaque imaging before Carotid Artery Stenting (MR-CAS) trial |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2012/10/28 18:34:19 |
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Basic information
Public title
Magnetic Resonance plaque imaging before Carotid Artery Stenting (MR-CAS) trial
Acronym
Magnetic Resonance plaque imaging before Carotid Artery Stenting (MR-CAS) trial
Scientific Title
Magnetic Resonance plaque imaging before Carotid Artery Stenting (MR-CAS) trial
Scientific Title:Acronym
Magnetic Resonance plaque imaging before Carotid Artery Stenting (MR-CAS) trial
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the relationship between preoperative MR plaque imaging and clinical results after carotid artery stenting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Major adverse event (MAE) including any stroke, myocardial infarction, or death within 90 (+/-10) days after CAS
Key secondary outcomes
1) Relationship between MR plaque imaging and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
2) Relationship between method of cerebral protection and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
3) Relationship between laboratory data and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
4) Relationship between stent type and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient scheduled for CAS from Oct. 1st, 2011 to Sept. 30th, 2013
2) Patients can receive MR plaque imaging before CAS
3) Patient who signed an informed consent form
Key exclusion criteria
Patients who are judged as inappropriate to participate in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Homepage URL
http://ab-cas.jp/
s-yoshi@gifu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Gifu University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ichinomiya West Hospital
Ube Kosan Central Hospital
Kizawa Memorial Hospital
Toki Municipal Hospital
Hyogo College of Medicine
Hiroshima University Hospital
Fukuroi Municipal Hospital
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
| 2012 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
) Relationship between MR plaque imaging and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
2) Relationship between method of cerebral protection and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
3) Relationship between laboratory data and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
4) Relationship between stent type and MAEs or the number of newly appeared high intensity signals 1-3 days after CAS
Management information
Registered date
| 2012 | Year | 10 | Month | 28 | Day |
Last modified on
| 2012 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010807
