UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041706
Receipt No. 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

* 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 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
Email 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
Email y0493589m@hotmail.co.jp

Sponsor
Institute Kobe University Hospital department of cardiovascular medicne
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026975

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.