UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005260 |
|---|---|
| Receipt number | R000006257 |
| Scientific Title | Efficacy of myocardial protection by nicorandil during open-heart surgery under cardiopulmonary bypass |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2018/09/20 14:24:51 |
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Basic information
Public title
Efficacy of myocardial protection by nicorandil during open-heart surgery under cardiopulmonary bypass
Acronym
Myocardial protection by nicorandil
Scientific Title
Efficacy of myocardial protection by nicorandil during open-heart surgery under cardiopulmonary bypass
Scientific Title:Acronym
Myocardial protection by nicorandil
Region
| Japan |
Condition
Condition
valvular heart disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Operative medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of myocardial protection by nicorandil during open-heart surgery under cardiopulmonary bypass
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemodynamics, markers for myocardial damage(CK-MB,TnT,H-FABP etc) at five time points(anesthesia induction, just, 1hr, 5hr and 24hr after cardiopulmonary bypass stopped).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aortic valve surgery
transvenous administration of nicorandil (6mg/hr) for 24 hours.
Interventions/Control_2
aortic valve surgery
control
Interventions/Control_3
cardiac valve surgery(except aortic valve), transvenous administration of nicorandil (6mg/hr) for 24 hours.
Interventions/Control_4
cardiac valve surgery(except aortic valve)
control
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
elective heart valve replacement or plasty surgery
Key exclusion criteria
emergency surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiko Jomura |
Organization
Kansai Medical University Hirakata hospital
Division name
Dept. Anesthesiology
Zip code
Address
2-3-1 Shin-machi Hirakata-city Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Jomura |
Organization
Kansai Medical University Hirakata hospital
Division name
Dept. Anesthesiology
Zip code
Address
2-3-1 Shin-machi Hirakata-city Osaka
TEL
Homepage URL
Sponsor or person
Institute
Kansai Medical University, Dept. Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University, Dept. Anesthesiology
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | 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
| 2011 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006257
