UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010512 |
|---|---|
| Receipt number | R000012295 |
| Scientific Title | The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery |
| Date of disclosure of the study information | 2013/04/16 |
| Last modified on | 2013/04/16 21:21:32 |
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Basic information
Public title
The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Acronym
The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Scientific Title
The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Scientific Title:Acronym
The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Region
| Japan |
Condition
Condition
valvular disease, angina
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The bisoprolol effective medication method for prevention of atrial fibrillation coronary after cardiac surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
atrial fibrillation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
preoperation
Interventions/Control_2
preoperation and postoperation
Interventions/Control_3
postoperation
Interventions/Control_4
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient who undergo valve replacement and coronary artery bypass
Key exclusion criteria
1 heart failure, acidosis,
peripheral circulatory failure,
pheochromocytoma
2 LVEF<30%
3 HR<55
4 AMI(within 2 week)
5 atrial fibrillation
6 be-ta blocker(except bisoprolol) medication
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | takano tamaki |
Organization
shinshu University school of medicine
Division name
cardiovascular surgery
Zip code
Address
3-1-1 Asahi, Matumoto-shi, Nagano-ken, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
shinshu University school of medicine
Division name
cardiovascular surgery
Zip code
Address
TEL
0263372657
Homepage URL
Sponsor or person
Institute
department of cardiovascular surgery,
shinshu University school of medicine
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
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 | 04 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 17 | 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
| 2013 | Year | 04 | Month | 16 | Day |
Last modified on
| 2013 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012295
