UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023601 |
|---|---|
| Receipt number | 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 11:15:54 |
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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
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
tochiya.mayu.hp@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027173
