UMIN-CTR Clinical Trial

Basic information
Public title	The investigation of influence of glucose fluctuation on in vivo plaque characteristics and vascular healing reaction by directional coronary atherectomy.
Acronym	Influence of gluCOSe fluctuation on coronary atherosclerosis(ICOS).
Scientific Title	The investigation of infuluence of glucose fluctuation on coronary atherosclerosis assessed by continuous glucose monitoring and directional coronary atherectomy
Scientific Title:Acronym	The association of glucose torelance and coronary atherosclerosis assessed by CGM and DCA.
Region	Japan

Condition
Condition	Coronary artery disease. Atherosclerosis.
Classification by specialty	Medicine in general Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between coronary atherosclerosis obtained by directional atherectomy (DCA) and abnormal glucose metabolism (glucose fluctuation), and to determine the effect on coronary vessel healing after DCA.
Basic objectives2	Others
Basic objectives -Others	The investigation of coronary artery healing after DCA treatment.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The evaluation of the relationship between vascular healing response after DCA and abnormal gulucose metabolism.
Key secondary outcomes	The evaluation of atherosclerosis by histological and single-cell RNA sequencing and its association with abnormal gulucose metabolism.

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) Patients 20 years of age or older at the time of percutaneous coronary intervention (PCI). (2) Patients scheduled to undergo PCI with DCA. (3) Patients who have obtained written consent from the patient.
Key exclusion criteria	(1) Patients who do not have written consent from the person in question. (2) Any other patients deemed inappropriate by the investigators in charge of this study.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Yamamoto
Organization	Hyogo Brain and Heart Centor
Division name	The division of Cardiovascular medicine
Zip code	6700981
Address	Saisho-Kou520, Himeji, Hyogo, Japan
TEL	079-293-3131
Email	y0493589m@hotmail.co.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Yamamoto
Organization	Hyogo Brain and Heart Centor
Division name	The division of Cardiovascular medicine
Zip code	6700981
Address	Kou-Saisyo520, Himeji, Hyogo, Japan
TEL	0792933131
Homepage URL
Email	y0493589m@hotmail.co.jp

Sponsor
Institute	Hyogo Brain and Heart Centor
Institute
Department

Funding Source
Organization	Hyogo Brain and Heart Centor
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kobe University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo Brain and Heart Centor
Address	Kou-Saisyo520, Himeji, Hyogo, Japan
Tel	0792933131
Email	y0493589m@hotmail.co.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	兵庫県立姫路循環器病センター

Other administrative information
Date of disclosure of the study information	2020 Year 06 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	2020 Year 05 Month 19 Day
Date of IRB	2020 Year 07 Month 14 Day
Anticipated trial start date	2020 Year 07 Month 14 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing

Management information
Registered date	2020 Year 05 Month 31 Day
Last modified on	2020 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046331

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.