UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003485 |
|---|---|
| Receipt number | R000003313 |
| Scientific Title | Brain Injury after Off-pump Coronary Artery Bypass Surgery-Evaluation by Magnetic Resonance Image and Cervical Echo- |
| Date of disclosure of the study information | 2010/04/25 |
| Last modified on | 2016/04/25 22:28:59 |
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Basic information
Public title
Brain Injury after Off-pump Coronary Artery Bypass Surgery-Evaluation by Magnetic Resonance Image and Cervical Echo-
Acronym
BIOMEC
Scientific Title
Brain Injury after Off-pump Coronary Artery Bypass Surgery-Evaluation by Magnetic Resonance Image and Cervical Echo-
Scientific Title:Acronym
BIOMEC
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of brain injury after off-pump CABG by MRI and cervical echo
Basic objectives2
Others
Basic objectives -Others
Whether carotid stenosis affect the brain injury after off-pump CABG
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate if the carotid stenosis have an affect on postoperative delirium in off-pump CABG
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Performing MRI perioperatively
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 for off-pump CABG
Patients with preoperative cervical Echo
Patients with preoperative MRI
Key exclusion criteria
contraindication of MRI
patients with psychological disease
Kawasaki disease
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Yoshitani |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
sohtamikaze@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Yoshitani |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
Address
National Cerebral and Cardiovascular Center, Dpt. Anesth
TEL
0668335012
Homepage URL
sohtamikaze@gmail.com
Sponsor or person
Institute
National Cerebral and Cardiovascular Center, department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Japanese Government
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2010 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 13 | Day |
Last modified on
| 2016 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003313
