UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009735 |
|---|---|
| Receipt number | 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 18:46:25 |
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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
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
kazuki_anraku@yahoo.co.jp
Sponsor or person
Institute
Teikyo University School of Medicine
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011282
| 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 |
