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
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
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
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
