UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003842 |
|---|---|
| Receipt number | R000003790 |
| Scientific Title | Inflammation of Diabetic and non-diabetic Epicardial Adipose tissue in patients undergoing Coronary Artery Bypass surgery Study |
| Date of disclosure of the study information | 2010/06/30 |
| Last modified on | 2011/01/07 12:09:25 |
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Basic information
Public title
Inflammation of Diabetic and non-diabetic Epicardial Adipose tissue in patients undergoing Coronary Artery Bypass surgery Study
Acronym
IDEA-CAB Study
Scientific Title
Inflammation of Diabetic and non-diabetic Epicardial Adipose tissue in patients undergoing Coronary Artery Bypass surgery Study
Scientific Title:Acronym
IDEA-CAB Study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between the inflammation in epicardial adipose tissue and the formation of coronary aterosclerosis
in patients with coronary artery disease
Basic objectives2
Others
Basic objectives -Others
To investigate the specific inflammation in epicardial adipose tissue which makes the coronary atherosclerosis of diabetics more diffuse and calcified
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
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing elective primary isolated off pump coronary artery bypass grafting
patients undergoing open heart surgery due to valve disease or congenital heart disease without coronary artery stenosis
Key exclusion criteria
chronic renal failure with hemodialysis
neoplasma or history of neoplasma
autoimmune disease or steroid intaking
aortic aneurysm
aortic or mitral valve stenosis
active infectious endocarditis
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Inaba |
Organization
Juntendo university hospital
Division name
Department of cardiothoracic surgery
Zip code
Address
Hongo 3-1-3, Bunkyouku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo university hospital
Division name
Department of cardiothoracic surgery
Zip code
Address
TEL
0338133111
Homepage URL
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
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 | 06 | Month | 30 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | 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
Samples are taken from adipose tissues
(CABG case:epicardial,pericardial and subcutaneous.Control case:pericardial and subcutaneous) during elective cardiac operation.Expression of adipocytekines which may affect coronary artery atherosclerosis is evaluated by real-time PCR. Then, inflammatory cell infiltration and significant change of adipocytekines in real-time PCR are investigated by immunohistochemical staining.
Management information
Registered date
| 2010 | Year | 06 | Month | 29 | Day |
Last modified on
| 2011 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003790
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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