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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023428
Receipt No. R000026976
Scientific Title The association between monocyte subsets and coronary plaque characteristics-a retrospective study-
Date of disclosure of the study information 2016/08/20
Last modified on 2018/08/07

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Basic information
Public title The association between monocyte subsets and coronary plaque characteristics-a retrospective study-
Acronym The association between monocyte and coronary plaque characteristics in patients with angina pectoris
Scientific Title The association between monocyte subsets and coronary plaque characteristics-a retrospective study-
Scientific Title:Acronym The association between monocyte and coronary plaque characteristics in patients with angina pectoris
Region
Japan

Condition
Condition Angina pectoris with impaired glucose torerance or diabetes mellitus and patients who are suspected that disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the effect of monocyte subsets on coronary plaque properties, and to investigate the association of glucose fluctuation,inflammatory cells, immune cells assessd by flowcytometry and plaque properties.
Basic objectives2 Others
Basic objectives -Others Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.Coronary plaque characteristics using the optical coherence tomography (OCT) and intravascular ultrasound(IVUS) and coronary angiography
2.Association between atherosclerosis assessed by IVUS or OCT and subsets of monocyte.
3.Circadian rhythm in the blood glucose using CGM
Key secondary outcomes 1.Glucose, IRI, CPR assesed by glucose tolerance test.
2.Intima- media thickness(IMT) assesed by carotid artery ultrasound.
3.Endothelial function assessed by FMD.
4.Inflammatory cell marker associated with arteriosclerosis.

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

Not applicable
Gender Male and Female
Key inclusion criteria Retrospective observational study.
Patinets who was undergone coronary angiography and monocytes subsets using flow cytometry after April 2015 in Kobe university
Key exclusion criteria 1)Patients with renal dysfunction(Creatinin level is more than 2.0mg/ml) or reciving hemodaialysis.
2)the patients who have had heart failure (NYHA >III)
3)patients with any malignant tumor or very ill condition
4)pregnant women or women at risk of becoming pregnant
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinke Toshirou
Organization Kobe univercity hospital
Division name Cardiovascular medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,650-0017
TEL 078-382-5111
Email shinke@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamamoto Hiroyuki
Organization Kobe university hospital
Division name Cardiovascular medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,650-0017
TEL 078-382-5111
Homepage URL
Email y0493589m@hotmail.co.jp

Sponsor
Institute Kobe University Hospital department of cardiovascular medicne
Institute
Department

Funding Source
Organization Kobe univetsity
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
2016 Year 08 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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 retrospecive observational study

Management information
Registered date
2016 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026976

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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