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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028918
Receipt No. 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

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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
Institute Shinshu University school of Health Sciences
Institute
Department

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
URL(English) https://upload.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


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