UMIN-CTR Clinical Trial

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