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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040597
Receipt No. R000046331
Scientific Title The investigation of infuluence of glucose fluctuation on coronary atherosclerosis assessed by continuous glucose monitoring and directional coronary atherectomy
Date of disclosure of the study information 2020/06/01
Last modified on 2020/12/13

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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


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