UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010654 |
|---|---|
| Receipt number | R000012461 |
| Scientific Title | Accumulation of epicardial adipose tissue is associated with cardiovascular disease: Histopathological study |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2016/11/09 20:54:35 |
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Basic information
Public title
Accumulation of epicardial adipose tissue is associated with cardiovascular disease: Histopathological study
Acronym
EAT and CAD histopathology
Scientific Title
Accumulation of epicardial adipose tissue is associated with cardiovascular disease: Histopathological study
Scientific Title:Acronym
EAT and CAD histopathology
Region
| Japan |
Condition
Condition
coronary artery disease and valvular heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucide whether epicardial adipose accumulation is associated with coronary atherosclerosis and ventricular hypertropy by histopathological approarch in patients undergoing open heart surgery
Basic objectives2
Others
Basic objectives -Others
pathological evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
expression of adipocytokines
Key secondary outcomes
none
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Coronary artery disease or valvular heart disease patients undergoing CABG and/or valvular surgery 2) age>=30 years old. 3) all patients had undergone cardiac catheter examination, echocardiography, and cardiac CT angiography before the surgery
Key exclusion criteria
Critical heart failure, shock status, nonconciousness
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideya Yamamoto |
Organization
Hiroshima University, Graduate School of Biomedical and Health Sciences
Division name
Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima City
TEL
082-257-5540
hideyayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideya Yamamoto |
Organization
Hiroshima University, Graduate School of Biomedical and Health Sciences
Division name
Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima City
TEL
082-257-5540
Homepage URL
http://home.hiroshima-u.ac.jp/cardio
hideyayama@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Hiroshima University, Graduate School of Biomedical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University, Graduate School of Biomedical and Health Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | 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
We expect that significant differences are observed with regard to expression of adiponectin and other inflammatory cytokines compared between with and without coronar artery disease.
Management information
Registered date
| 2013 | Year | 05 | Month | 07 | Day |
Last modified on
| 2016 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012461
| Research Plan | |
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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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| Registered date | File name |
