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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023601
Receipt No. R000027173
Scientific Title Retrospective observational study about the Cardiovascular complications of diabetes
Date of disclosure of the study information 2016/08/15
Last modified on 2016/08/12

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Basic information
Public title Retrospective observational study about the Cardiovascular complications of diabetes
Acronym Study of the Diabetic Cardiovascular complications
Scientific Title Retrospective observational study about the Cardiovascular complications of diabetes
Scientific Title:Acronym Study of the Diabetic Cardiovascular complications
Region
Japan

Condition
Condition Type2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim of this study is to investigate novel risk factor of cardio- and cerebro-vascular disease in type2 diabetic patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of acute coronary artery disease, stroke or all cause mortality
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ype 2 diabetes patients admitted to our department between January 2001 and March 2014 who can be monitored for at least 2 years before entry
Key exclusion criteria None
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Kishimoto
Organization National Cerebral and Cardiovascular Center
Division name Division of Atherosclerosis and Diabees
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Email kishimot@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayu Tochiya
Organization National Cerebral and Cardiovascular Center
Division name Division of Atherosclerosis and Diabees
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email tochiya.mayu.hp@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2010 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Anual investigation of medical record about the incidence of major cardiovascular event is performed. Subjects who terminated ambulatory care in National Cerebral cardiovacular ceter are performed the investigation by phone about the incidence of major cardiovascular event

Management information
Registered date
2016 Year 08 Month 12 Day
Last modified on
2016 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027173

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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