UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006879 |
|---|---|
| Receipt number | R000007059 |
| Scientific Title | Effect of Intensive LDL-C Lowering with High-dose Atorvastatin on Inflammation and Postoperative Organ Damage in Patients Undergone Coronary Artery Bypass Surgery |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2017/12/16 09:09:30 |
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Basic information
Public title
Effect of Intensive LDL-C Lowering with High-dose Atorvastatin on Inflammation and Postoperative Organ Damage in Patients Undergone Coronary Artery Bypass Surgery
Acronym
Effect of high-dose Atrovastatin on inflammation
Scientific Title
Effect of Intensive LDL-C Lowering with High-dose Atorvastatin on Inflammation and Postoperative Organ Damage in Patients Undergone Coronary Artery Bypass Surgery
Scientific Title:Acronym
Effect of high-dose Atrovastatin on inflammation
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Cardiovascular surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of high-dose Atrovastatin on inflammation of epicardial adipose tissue.
Basic objectives2
Others
Basic objectives -Others
To investigate whether high-dose statin administration affect to the inflammation of epicardial adipose tissue
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression of inflammatory cytokines and adipocytekines from each adipose tissues
Key secondary outcomes
Lipid profiles, inflammatory markers, adipocytekines and blood cell counts in peripheral blood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
20mg/day of Atrovastatin
Interventions/Control_2
Starting-dose statin
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing elective primary isolated coronary artery bypass surgery
Key exclusion criteria
Hemodialysis
Undergoing with intensive statin therapy
Stroke or acute myocardial infarction
Emrgerncy/Urgent surgery
Sever liver dysfunction
Pregnancy (including suspected)
Allergy or history of allergy
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taira Yamamoto |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular surgery
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo
TEL
0338133111
tyamamo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taira Yamamoto |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular surgery
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
tyamamo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo Urayasu Hospital
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
| 2012 | Year | 01 | 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 | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 12 | Day |
Last modified on
| 2017 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007059
