UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011977 |
|---|---|
| Receipt number | R000013991 |
| Scientific Title | Evaluation for the usefulness of intraoperative monitoring by transesophageal echocardiography |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2020/03/10 14:58:36 |
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Basic information
Public title
Evaluation for the usefulness of intraoperative monitoring by transesophageal echocardiography
Acronym
Evaluation for the usefulness of intraoperative monitoring by transesophageal echocardiography
Scientific Title
Evaluation for the usefulness of intraoperative monitoring by transesophageal echocardiography
Scientific Title:Acronym
Evaluation for the usefulness of intraoperative monitoring by transesophageal echocardiography
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the morphological changes in mitral annulus using real time three-dimensional transesophageal echocardiography during Off-pump Coronary Artery Bypass Graft Surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
annular height
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing OPCAB for revascularization of the coronary artery
Key exclusion criteria
Patients with a history of mitral valve surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Toyama |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology&Critical care
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido
TEL
0166682583
toyama12@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Toyama |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology&Critical care
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido
TEL
0166682583
Homepage URL
toyama12@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido
Tel
0166682187
yukitoyama777@yahoo.co.jp
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
| 2013 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
http://dx.doi.org/10.1053/j.jvca.2017.08.023
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1053/j.jvca.2017.08.023
Number of participants that the trial has enrolled
34
Results
In the LCX and RCA positions, the height of the mitral annulus was significantly lower compared to the heart in the physiologic position .
The percent change in the height of the mitral annulus in the LCX position was significantly greater in the MR deterioration group than in the MR non-deterioration group . The percent change in the height of the mitral annulus in the RCA position was significantly greater in the MR deterioration group than in the MR non-deterioration group .
Results date posted
| 2020 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing OPCAB of the left circumflex artery (LCX) and the right coronary artery (RCA) were eligible for inclusion.
Participant flow
The institutional review board of Asahikawa Medical University approved the study protocol and all patients provided written informed consent.
Adverse events
none
Outcome measures
The primary end-point was the height of the mitral annulus. The secondary end-points were anteroposterior and intercommissural diameter, annulus perimeter, and surface area of the mitral annulus.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Three-dimensional TEE data of the mitral valve were obtained prior to skin incision and after the heart was positioned for revascularization of the coronary artery.
Following parameters of the mitral annular structure were measured using plug-in software; bicommissural diameter, anteroposterior diameter, perimeter, annular area, annular height, annular height index.
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013991
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