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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010766
Receipt No. 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

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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
Email

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
Email kennosuke.atmm3@gmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012589

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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