UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012281 |
|---|---|
| Receipt number | R000014346 |
| Scientific Title | Observation of mitral valve morphology before and after induction of anesthesia-A prospective observational study |
| Date of disclosure of the study information | 2013/11/13 |
| Last modified on | 2013/11/12 22:14:49 |
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Basic information
Public title
Observation of mitral valve morphology before and after induction of anesthesia-A prospective observational study
Acronym
Observation of mitral valve morphology before and after induction of anesthesia-A prospective observational study
Scientific Title
Observation of mitral valve morphology before and after induction of anesthesia-A prospective observational study
Scientific Title:Acronym
Observation of mitral valve morphology before and after induction of anesthesia-A prospective observational study
Region
| Japan |
Condition
Condition
Patients with mitral valve regurgitation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe mitral valve morphology before and after induction of anesthesia in patients who have mitral valve prolapse.
Basic objectives2
Others
Basic objectives -Others
To observe mitral valve morphology before and after induction of anesthesia in patients who have mitral valve prolapse.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of mitral valve morphology between pre- and post-induction of anesthesia
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo mitral valve replacement or mitral valve plasty with or without comcomitant surgical procedures such as tricuspid valve annuloplasty.
Key exclusion criteria
Patients in whom transesophageal echocardiography use is contraindicated(ex. patients with esophageal varices).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikatsu Mita |
Organization
Saitama cardiovascular and respiratory center
Division name
Department of anesthesiology
Zip code
Address
1696 Itai, Kumagaya, Saitama, Japan
TEL
048-536-9900
mita.norikatsu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikatsu Mita |
Organization
Saitama cardiovascular and respiratory center
Division name
Department of anesthesiology
Zip code
Address
1696 Itai, Kumagaya, Saitama, Japan
TEL
048-536-9900
Homepage URL
mita.norikatsu@gmail.com
Sponsor or person
Institute
Saitama cardiovascular and respiratory center
Institute
Department
Personal name
Funding Source
Organization
Saitama cardiovascular and respiratory center
Organization
Division
Category of Funding Organization
Local Government
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
| 2013 | Year | 11 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe mitral valve morphology before and after induction of anesthesia and acquire data by using both 2D and 3D TEE. During anesthesia, we calculate systemic vascular resistance at several different timepoints. We observe mitral valve morphology and acquire data at each time point.
Management information
Registered date
| 2013 | Year | 11 | Month | 12 | Day |
Last modified on
| 2013 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014346
