UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028918
Receipt number R000033083
Scientific Title Perspective research concerning with the relationship between chronic obstructive pulmonary disease (COPD) and atherosclerosis.
Date of disclosure of the study information 2017/08/31
Last modified on 2017/08/30 20:38:25

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Basic information

Public title

Perspective research concerning with the relationship between chronic obstructive pulmonary disease (COPD) and atherosclerosis.

Acronym

COPD and atherosclerosis

Scientific Title

Perspective research concerning with the relationship between chronic obstructive pulmonary disease (COPD) and atherosclerosis.

Scientific Title:Acronym

COPD and atherosclerosis

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose in this study is to clarify the relationship between COPD and atherosclerosis.

Basic objectives2

Others

Basic objectives -Others

Cardio-cerebro-vascular disease has been demonstrated to be an important cause of death in COPD. It has been suggested that the chronic inflammation in lung spread to whole body and result in the aggravation of the development of atherosclerosis. The purpose in this study is to compare CAVI, ABI, and TBI, generally used as markers of atherosclerosis, among COPD and never smoker and current or past smokers without COPD.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

cardio ankle vascular index (CAVI)

Key secondary outcomes

Ankle-Brachial-Index (ABI) and Toe Brachial Index (TBI)


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

COPD is diagnosed in accordance with Japan COPD guideline and the patients with COPD over 65 years of old are recruited. The healthy volunteers of never smokers and current or past smokers without COPD over 65 years of old are also recruited from general population.

Key exclusion criteria

The patients who had moderate to severe arrhythmia, atrial fibrillation, peripheral circulatory failure, conspicuous heart failure, renal failure, impaired cognitive function or those who had suffered from respiratory tract infection or exacerbation of COPD during the preceding three months, and those who had been treated with narcotic agents due to insomnia are excluded.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keisaku Fujimoto

Organization

Shinshu University School of Health Sciences

Division name

Department of Clinical Laboratory Sciences

Zip code


Address

3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan

TEL

0263-37-2393

Email

keisaku@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keisaku Fujimoto

Organization

Shinshu University school of Health Sciences

Division name

Department of Clinical Laboratory Sciences

Zip code


Address

3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan

TEL

0263-37-2393

Homepage URL


Email

keisaku@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University school of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

Shinshu University school of Health Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Japan Boeringer Ingerheim Co., Ltd.


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

2017 Year 08 Month 31 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


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

Main results already published

Date of protocol fixation

2017 Year 08 Month 08 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 31 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 08 Month 30 Day

Last modified on

2017 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name