UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041706 |
|---|---|
| Receipt number | R000026975 |
| Scientific Title | The association between coronary plaque characteristics and glucose fluctuation assesed by coronary imaging devices and continuous glucose monitoring-a long term follow up study- |
| Date of disclosure of the study information | 2020/09/07 |
| Last modified on | 2020/09/07 11:53:13 |
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Basic information
Public title
The association between coronary plaque characteristics and glucose fluctuation assesed by coronary imaging devices and continuous glucose monitoring-a long term follow up study-
Acronym
The association between coronary plaque characteristics and glucose fluctuation -a long term follow up study-
Scientific Title
The association between coronary plaque characteristics and glucose fluctuation assesed by coronary imaging devices and continuous glucose monitoring-a long term follow up study-
Scientific Title:Acronym
The association between coronary plaque characteristics and glucose fluctuation -a long term follow up study-
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
YES
Objectives
Narrative objectives1
This study aims to investigate the impact of glucose fluctuation on long term outcome in patients with coronary artery disease, and to investigate the association of glucose fluctuation,inflammatory cells, immune cells assessd by flowcytometry and enterobacterial flora.
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Coronary plaque characteristics and neointimal characteristics in stent using the optical coherence tomography (OCT) and intravascular ultrasound(IVUS) and coronary angiography at the time of treatment, nine(six to twelve)months and three(twe to four)years.
2.Circadian rhythm in the blood glucose using CGM
3.Association between atherosclerosis assessed by IVUS or OCT and subsets of monocyte and Tcell.
Key secondary outcomes
The following at the time of treatment, nine(six to twelve)months and three(twe to four)years
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.Bacterial flora in the intestine.
5.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
Prospective observational study
Patients with impaired glucose torelance who have a plan to receive PCI for coronary artery disease.
Patinets with diagnosed or suspected impaired glucose torelance who had a history of coronary stenting.
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
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Shinke |
Organization
Kobe university hospital
Showa hospital
Division name
Cardiovascular medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,650-0017
TEL
078-382-5111
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Kobe university hospital
Division name
Cardiovascular medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,650-0017
TEL
078-382-5111
Homepage URL
y0493589m@hotmail.co.jp
Sponsor or person
Institute
Kobe University Hospital department of cardiovascular medicne
Institute
Department
Personal name
Funding Source
Organization
Kobe university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe university hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,650-0017
Tel
078-382-5111
chiken@med.kobe-u.ac.jp
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
| 2020 | Year | 09 | Month | 07 | 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
66
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 | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
1.IVUS and OCT analysis at the time of receiving PCI or stent follow up.
And carotid artery ultrasound, continuous glucose monitoring(CGM), flowcytometry, fecal examination at the time.
2.IVUS and OCT analysis,corotid artery ultrasound, CGM, flowcytometry, fecal examination at 9(from 6 to 12)months and 2(from 1 to 3)years after stent implantation.
Management information
Registered date
| 2020 | Year | 09 | Month | 07 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026975
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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