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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009735
Receipt No. R000011282
Scientific Title Evaluation of mitral valve annulus under displacement of the heart using three dimension transesophageal echocardiography during off-pump coronary artery bypass graft surgery
Date of disclosure of the study information 2013/01/09
Last modified on 2015/07/09

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Basic information
Public title Evaluation of mitral valve annulus under displacement of the heart using three dimension transesophageal echocardiography during off-pump coronary artery bypass graft surgery
Acronym Evaluation of mitral valve annulus under displacement of the heart using three dimension transesophageal echocardiography during off-pump coronary artery bypass graft surgery
Scientific Title Evaluation of mitral valve annulus under displacement of the heart using three dimension transesophageal echocardiography during off-pump coronary artery bypass graft surgery
Scientific Title:Acronym Evaluation of mitral valve annulus under displacement of the heart using three dimension transesophageal echocardiography during off-pump coronary artery bypass graft surgery
Region
Japan

Condition
Condition Corovary artery stenosis
Classification by specialty
Cardiology Anesthesiology Laboratory medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We are going to research the association between the formal change of the mitral valve annulus and the displacement of the heart during off-pump coronary artery bypass graft surgery by using three dimension transesophageal echocardiography.
Basic objectives2 Others
Basic objectives -Others he association between the formal change of the mitral valve annulus and the displacement of the heart
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes mitral valve area
Key secondary outcomes long and short diameter of the mitral valve, regurgitation of the mitral valve, systolic blood pressure, central venous pressure, cardiac output, saturation of central vein

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 who are going to undergo off-pump coronary artery bypass graft surgery, and be monitored with intraoperative transesophageal echocardiography
Key exclusion criteria Patients who do not consent to the study, have been undergone esophagectomy or esophagogasierectomy, have past history of esophageal stenosis, esophagotracheal fistula and esophageal trauma, have impaired left ventricle or mitral function, are undergone emergent surgery, have impaired cardiac, respiratory
, hepatic and renal function, and are judged inappropriate for study by an anesthesiologist.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Anraku
Organization Teikyo University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 2-11-1, kaga, itabashi-ku, Tokyo
TEL 03-3963-2687
Email kazuki_anraku@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Anraku
Organization Teikyo University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 2-11-1, kaga, itabashi-ku, Tokyo
TEL 03-3963-2687
Homepage URL
Email kazuki_anraku@yahoo.co.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 09 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 Terminated
Date of protocol fixation
2012 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 28 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 04 Month 30 Day
Date analysis concluded
2014 Year 05 Month 30 Day

Other
Other related information We observe the change in the mitral valve area and diameter, regurgitation before and after displacement of the heart by using three dimension transesophageal echocardiography.

Management information
Registered date
2013 Year 01 Month 09 Day
Last modified on
2015 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011282

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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