UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Brain Injury after Off-pump Coronary Artery Bypass Surgery-Evaluation by Magnetic Resonance Image and Cervical Echo-
Title of the study (Brief title)	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

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	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

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	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	Kenji Yoshitani
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Anesthesiology
Address	5-7-1 Fujishiro-dai, Suita, Osaka
TEL	06-6833-5012
Email	sohtamikaze@gmail.com

Public contact
Name of contact person	Kenji Yoshitani
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Anesthesiology
Address	National Cerebral and Cardiovascular Center, Dpt. Anesth
TEL	0668335012
Homepage URL
Email	sohtamikaze@gmail.com

Sponsor
Institute	National Cerebral and Cardiovascular Center, department of anesthesiology
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003313