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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||||
Condition | Coronary artery disease.
Atherosclerosis. |
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Classification by specialty |
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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 | |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | Nothing |
Management information | |||||||
Registered date |
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Last modified on |
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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 |