UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018326 |
|---|---|
| Receipt number | R000021065 |
| Scientific Title | A study of the relationship between coronary plaque findings and indices of glycemic variability |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2018/01/15 18:25:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of the relationship between coronary plaque findings and indices of glycemic variability
Acronym
Kobe variability 2 study
Scientific Title
A study of the relationship between coronary plaque findings and indices of glycemic variability
Scientific Title:Acronym
Kobe variability 2 study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between coronary plaque findings and indices of glycemic variability on CGM
Basic objectives2
Others
Basic objectives -Others
To deterimin the most reliable index of glycemic variability to predict dangerous plaque
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To deterimin the most reliable index of glycemic variability to predict dangerous plaque
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who
1)LDL-Chol<120 mg/dl under statin adminsitration or < 100 mg/dl under other treatment for dislipidemia, including lifestyle modification
Key exclusion criteria
1) PCI for acute coronary syndrome
2) unsuitable anatomy of virtual histology(VH) or optical coherence tomography(OCT)-IVUS
3) poor imaging of VH or OCT-IVUS
4) hemodialysis
5) inflammatory disease
6) shock or low cardiac output
7) malignancy
8) When consecutive 48-hour data are not provided from CGM
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KazuhikoSakaguchi |
Organization
Kobe University school of medicine
Division name
Devision of diabetes and endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KazuhikoSakaguchi |
Organization
Kobe University school of medicine
Division name
Devision of diabetes and endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Devision of diabetes and endocrinology,
Kobe University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Donation
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 10 | Month | 31 | Day |
Other
Other related information
To investigate the relationship between coronary plaque vulnetability and indices of glycemic variability
[Objectives]
Fifty-three consecutive patients who had undergone percutaneous coronary intervention (PCI) for CAD from June 2012 to May 2014 and who fulfilled the inclusion criteria
[Data Collection]
age, sex, height, weight, medication, durations of diabetes, comorbidities and past histories, family history, smoking, blood pressure
laboratory data: LDL-C, TG, HDL-C, FFA, HbA1c, GA, 1,5-AG, BUN, Cre, eGFR, BNP, Hb, CRP
LVEF(%)
IVUS study: Necrotic core %, Fibrous %, Calcium %, OCT-lipid
CGM data: Subcutaneous glucose concentration
Management information
Registered date
| 2015 | Year | 07 | Month | 15 | Day |
Last modified on
| 2018 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021065
