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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003842
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntendo university hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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