UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040597 |
|---|---|
| Receipt number | 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 09:32:56 |
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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
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
y0493589m@hotmail.co.jp
Sponsor or person
Institute
Hyogo Brain and Heart Centor
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046331
