UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014690 |
|---|---|
| Receipt number | 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 21:27:53 |
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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
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
ko_mi514@yahoo.co.jp
Public contact
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
ko_mi514@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017076
| 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 |
