UMIN-CTR Clinical Trial

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

Atherosclerosis

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

all-cause death

Key secondary outcomes

cardiovascular event
cardiovascular death
PWV value
ABI value

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyushu University

Institute

Department

Personal name

Organization

Public Trust Japan Arteriosclerosis Prevention Fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2013

Year

07

Month

22

Day

Last modified on

2015

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013065