UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010620 |
|---|---|
| Receipt number | R000012418 |
| Scientific Title | The effect of glucose variability, as assessed by continuous glucose monitoring system, on cardiovascular disease |
| Date of disclosure of the study information | 2013/04/30 |
| Last modified on | 2023/05/12 12:43:20 |
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Basic information
Public title
The effect of glucose variability, as assessed by continuous glucose monitoring system, on cardiovascular disease
Acronym
The effect of glucose variability on cardiovascular disease
Scientific Title
The effect of glucose variability, as assessed by continuous glucose monitoring system, on cardiovascular disease
Scientific Title:Acronym
The effect of glucose variability on cardiovascular disease
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the pattern of glucose variability by using continuous glucose monitoring system (CGMS) in the acute and chronic pahse of patients with cardiovascular disease.
To investigate the relationship of glucose variability to the clinical parameters (blood sample, ECG, UCG, CT, MRI, IVUS, OCT, etc) and prognosis of patients with cardiovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To evaluate the relationship of glucose variability to clinical parameters such as biomarker, cardiac function and atherosclerotic plaque, etc.in patients with acute coronary syndromes.
Key secondary outcomes
The relationship between the glucose variability and short- and long-term prognosis (death, non-fatal myocardial infarction, unstable angina, restenosis, heart failure,etc)
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 aged 20 years old or older at the time of consent.
2)Patients with cardiovascular disease.
3)Patients providing written consent for participation in this study on their own volition after receving a through explanation about the study.
Key exclusion criteria
1) Patients with unwillingness to
participate or Patients whose conset could not be aquired.
2)Patients judged to be unsuitable for participation for medical reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kimura |
Organization
Yokohama City University Medical Center
Division name
Devision of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
c_kimura@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Hanashima |
Organization
Yokohama City University Medical Center
Division name
Devision of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
yugo@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama City University Ethics Committee
Address
3-9 Fukuura,Kanazawa-ku,Yokohama 236-0004 Japan
Tel
045-370-7629
nextjim1@yokohama-cu.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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Average period of CGMS monitoring is 48~72 hours per a time.After monitoring, we will follow the patients prognosis. CGMS monitoring will be performed again if the attending doctor judges the nessecity to do so.
Management information
Registered date
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012418
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
