UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007280 |
|---|---|
| Receipt number | R000008588 |
| Scientific Title | Prospective study for the association between peri-coronary adipose tissue and coronary atherosclerosis |
| Date of disclosure of the study information | 2012/02/13 |
| Last modified on | 2012/02/13 16:19:12 |
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Basic information
Public title
Prospective study for the association between peri-coronary adipose tissue and coronary atherosclerosis
Acronym
Peri-coronary adipose tissue and coronary atherosclerosis
Scientific Title
Prospective study for the association between peri-coronary adipose tissue and coronary atherosclerosis
Scientific Title:Acronym
Peri-coronary adipose tissue and coronary atherosclerosis
Region
| Japan |
Condition
Condition
Patients with coronary artery disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epicardial adipose tissue (EAT) is recognized as an important inflammatory tissue causing coronary atherosclerosis. Recently increased EAT volume is reported to be an independent risk factor for coronary artery disease. The aim of this study is to compare expression of inflammatory mediators in peri-coornary and non peri-coronary adipose stores in patients with elective coronary artery bypass grafting.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1; Blood examination (blood cell count, blood urea nitrogen, creatinine, glucose, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglyceride, high-sensitive C-reactive protein, HbA1c, BNP, high-sensitive troponin T, high-sensitive monocyte chemoattractant protein-1, high-sensitive interleukin-1be-ta, high-sensitive interleukin-6, high-sensitive tumor necrotic factor-alfa)
2; Adipose tissue (high-sensitive monocyte chemoattractant protein-1, high-sensitive interleukin-1be-ta, high-sensitive interleukin-6, high-sensitive tumor nectotic factor-alfa)
3; Coronary computed tomographic angiography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blood examination and coronary computed tomographic angiography
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 who are scheduled for elective coronary artery bypass grafting
Key exclusion criteria
Patients treated with hemodialysis and/or with history of open heart surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shota Fukuda |
Organization
Osaka Ekisaikai Hospital
Division name
Department of Medicine
Zip code
Address
2-1-10 Honden, Nishi-ku, Osaka 550-0022, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka Ekisaikai Hospital
Division name
Department of Medicine
Zip code
Address
TEL
Homepage URL
h-syouta@mve.biglobe.ne.jp
Sponsor or person
Institute
Osaka Ekisaikai Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Ekisaikai 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
| 2012 | Year | 02 | Month | 13 | 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
| 2012 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
Management information
Registered date
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2012 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008588
