UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010766 |
|---|---|
| Receipt number | R000012589 |
| Scientific Title | The Effect of Epicardial fat on non culprit plaque in patients with coronary artery disease: IVUS and OCT analysis |
| Date of disclosure of the study information | 2013/05/20 |
| Last modified on | 2015/12/25 22:50:27 |
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Basic information
Public title
The Effect of Epicardial fat on non culprit plaque in patients with coronary artery disease: IVUS and OCT analysis
Acronym
Epicardial fat and non culprit plaque
Scientific Title
The Effect of Epicardial fat on non culprit plaque in patients with coronary artery disease: IVUS and OCT analysis
Scientific Title:Acronym
Epicardial fat and non culprit plaque
Region
| Japan |
Condition
Condition
Angina Pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the epicardial fat volume affect the progression and stability of the nonculprit plaques analysed by IVUS and OCT
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in component of coronary artery plaque measured by iMAP-IVUS and OCT
Key secondary outcomes
-Vessel volume,Lumen volume,Plaque volume
-Cardiovascular composite events(cardiovascular death,nonfatal myocardial infarction,nonfatal cerebral infarction,unstable angina,revascularization except target lesion revascularization)
-Changes of serum lipid(TC,LDL,HDL,TG,EPA/AA ratio)
-Others marker(hs^CRP)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Signed written informed consent
-Plan to undergo PCI
Key exclusion criteria
-Patient who has the past history of PCI or CABG
-Patient who has renal dysfunction
(serum Cr level >1.5mg/dl)
-MSCT was not performed within 3months before CAG
-CTO lesion
-Severe calcification lesion
-Patient who judged that doctor in charge is improper
Target sample size
59
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kennosuke Yamashita |
Organization
Showa University Northern Yokohama Hospital.
Division name
Division of cardiology and cardiac catheterization laboratory
Zip code
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
TEL
045-949-7000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kennosuke Yamashita |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of cardiology and cardiac catheterization laboratory
Zip code
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
TEL
045-949-7000
Homepage URL
kennosuke.atmm3@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital.
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 21 | Day |
Other
Other related information
The Effect of Epicardial fat on non culprit plaque in patients with coronary artery disease: IVUS and OCT analysis
Management information
Registered date
| 2013 | Year | 05 | Month | 20 | Day |
Last modified on
| 2015 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012589
| Research Plan | |
|---|---|
| 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 |
