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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011245
Receipt No. R000013065
Scientific Title Kyushu Prevention Study of Atherosclerosis
Date of disclosure of the study information 2013/07/22
Last modified on 2015/11/12

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Basic information
Public title Kyushu Prevention Study of Atherosclerosis
Acronym Kyushu Prevention Study of Atherosclerosis
Scientific Title Kyushu Prevention Study of Atherosclerosis
Scientific Title:Acronym Kyushu Prevention Study of Atherosclerosis
Region
Japan

Condition
Condition Atherosclerosis
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Atherosclerosis has been widely accepted as
a significant risk of all-cause death or cardiovascular events and death.
However there are few studies assessing the
factors relating cardiovascular events and early atherosclerosis.
Recently Pulse Wave Velocity (PWV) and
Ankle brachial index (ABI) have been
revealed as the reproducible and convenient index
for atherosclerosis.
This study aims to investigate the risk
factors of atherosclerosis by using ABI and PWV as the index of atherosclerosis
in Japanese diabetes on large scale population.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes all-cause death
Key secondary outcomes cardiovascular event
cardiovascular death
PWV value
ABI value

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Outpatients with diabetes who were regularly visiting Kyushu University Hospital, its 17 related hospitals, and University of the Ryukyus, its 6 related hospitals
Key exclusion criteria Patients under 20 and over 85 years old.
Target sample size 6000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toyoshi Inoguchi
Organization Kyushu University
Division name Innovation Center for Medical Redox Navigation
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5284
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Toyoshi Inoguchi
Organization Kyushu University
Division name Innovation Center for Medical Redox Navigation
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Public Trust Japan Arteriosclerosis Prevention Fund
Organization
Division
Category of Funding Organization Other
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
2013 Year 07 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This observational study included 3981 diabetic patients (61.0(SD=11.8) years of age, 59.4% men), registered in the Kyushu Prevention Study for Atherosclerosis. Patients were divided into 3 groups according to the value of ABI at baseline:ABI <0.90 (abnormal ABI:354 patients), 0.91<ABI<0.99 (borderline ABI:333 patients), and 1.00<ABI<1.40 (normal ABI:3294 patients). 
Cumulative incidence of all-cause death was significantly higher in patients with abnormal and borderline ABI than in those with normal ABI (34.4% vs.13.5%, P<0.0001 and 26.1% vs.13.5%, P<0.0001, respectively). In multivariate analysis, the risks for all-cause death in patients with abnormal ABI (HR:2.16; 95%CI:1.46-3.14; P=0.0002) and borderline ABI (HR:1.78; 95%CI:1.14-2.70; P=0.01) were significantly higher than in those with normal ABI. The incidence of PAD was remarkably higher in patients with borderline ABI than in those with normal ABI (32.2% vs.9.0%, P<0.0001). After adjustment, the risk for PAD was significantly higher in patients with borderline ABI than in those with normal ABI (HR:3.10; 95%CI:1.90-4.95; P<0.0001).
Borderline ABI in diabetic patients was associated with significantly higher risks for mortality and PAD compared with normal ABI.
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
2000 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2001 Year 04 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 Outpatients with diabetes(n=4327)who were regularly visiting Kyushu University Hospital, its 17 related hospitals, and University of Ryukyus and its 6 related hospital, were enrolled from 2001 to 2003 in this survey. At baseline, a device "form PWV/ABI"(Omron Colin Co.)was used to measure systolic blood pressure in the arms and legs of each subjects, and ABI was automatically calculated by the device as the ratio of systolic blood pressure in the leg to that in the arm on each side. Valid information was available in 3981 diabetic patients.

Management information
Registered date
2013 Year 07 Month 22 Day
Last modified on
2015 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013065

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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