UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective observational study about the Cardiovascular complications of diabetes
Title of the study (Brief title)	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	Ichiro Kishimoto
Organization	National Cerebral and Cardiovascular Center
Division name	Division of Atherosclerosis and Diabees
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL	06-6833-5012
Email	kishimot@ncvc.go.jp

Public contact
Name of contact person	Mayu Tochiya
Organization	National Cerebral and Cardiovascular Center
Division name	Division of Atherosclerosis and Diabees
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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