UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004699 |
|---|---|
| Receipt number | R000005594 |
| Scientific Title | Elucidation of the mechanisms underlying cardioprotection by long-acting and ultrrashort-acting beta blockers in cardiac surgery |
| Date of disclosure of the study information | 2010/12/15 |
| Last modified on | 2013/06/14 10:50:23 |
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Basic information
Public title
Elucidation of the mechanisms underlying cardioprotection by long-acting and ultrrashort-acting beta blockers in cardiac surgery
Acronym
The role of beta-blocker on cardiac surgery
Scientific Title
Elucidation of the mechanisms underlying cardioprotection by long-acting and ultrrashort-acting beta blockers in cardiac surgery
Scientific Title:Acronym
The role of beta-blocker on cardiac surgery
Region
| Japan |
Condition
Condition
patients undergoing cardiac bypass surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to validate the potential of beta-blocker to protect cardiac muscle cell damage in cardiac bypass surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma fatty acid binding protein, and brain natriuretic peptide concentration was measured during the perioperative period of cardiac bypass surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
beta-blocker
Interventions/Control_2
non beta-blocker
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiac bypass surgery
Patients undergoing valve plasty and valve replacement
Key exclusion criteria
Sever Liver Disease, Muscle Disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Nakajima |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kawarmachi Hirokoji, Kamigyo, Kyoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
TEL
075-251-5633
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Kyoto Prefectural University of Medicine
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
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
| 2010 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 15 | 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
| 2010 | Year | 12 | Month | 09 | Day |
Last modified on
| 2013 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005594
