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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014690
Receipt No. R000017076
Scientific Title Relationship between glycemic variability and coronary plaque progression in patients with impaired glucose metabolism :Analysis by CGM and IVUS
Date of disclosure of the study information 2014/08/01
Last modified on 2014/07/28

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Basic information
Public title Relationship between glycemic variability and coronary plaque progression in patients with impaired glucose metabolism :Analysis by CGM and IVUS
Acronym Relationship between glycemic variability and coronary plaque progression in patients with impaired glucose metabolism
Scientific Title Relationship between glycemic variability and coronary plaque progression in patients with impaired glucose metabolism :Analysis by CGM and IVUS
Scientific Title:Acronym Relationship between glycemic variability and coronary plaque progression in patients with impaired glucose metabolism
Region
Japan

Condition
Condition Coronary artery disease. Abnormal glucose metabolism
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to assess the relationship between glycemic variability and coronary plaque progression in patients with abnormal glucose metabolism
Basic objectives2 Others
Basic objectives -Others Pathophysiology
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes mean BS
deviation summary frequency duration
Standard Deviation MAGE CONGA
Grayscale IVUS analysis
Volumetric analysis EEM CSA Lumen CSA PM CSA
VHIVUS analysis
Plaque composite classfy fibrous fibrofatty necrotic core dense calcium
Volume data
Key secondary outcomes VH-TFCA VH-FCA
HbA1C 1.5AG

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 1)Effort angina pectoris,Sillent myocardial ischemia,Unstable angina pectolis,Acute myocardial infarction
2)Implantation Drug eluting stent of PCI
3)Impaired glucose tolerance or DM
4)Informed consent obtained
Key exclusion criteria 1) cases with unstable vital
2) cases which are difficult for performing IVUS
3) cases with insulin therapy
4) cases with hemodialysis
5) cases which are unsuitable for CGM
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shunichi.Miyazaki
Organization Kinki University School of Medicine
Division name Division of Cardiology
Zip code
Address 2-377 oonodai osakasayama city oosaka
TEL 0723660221
Email ko_mi514@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kosuke.Fujita
Organization Kinki University
Division name Division of Cardiology
Zip code
Address 2-377 oonodai osakasayama city oosaka
TEL 072-366-0221
Homepage URL
Email ko_mi514@yahoo.co.jp

Sponsor
Institute Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
Institute
Department

Funding Source
Organization Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
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 近畿大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 08 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information IVUS CGM

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2014 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017076

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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