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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010620
Receipt No. 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 2018/07/17

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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
Middle name
Last name Kazuo Kimura
Organization Yokohama City University Medical Center
Division name Devision of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email c_kimura@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yugo Minamimoto
Organization Yokohama City University Medical Center
Division name Devision of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email yugo@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2019 Year 10 Month 01 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
2018 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012418

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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