UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005168 |
|---|---|
| Receipt number | R000006136 |
| Scientific Title | Observational study of changes in endothelial micro-particles in COPD patients |
| Date of disclosure of the study information | 2011/03/02 |
| Last modified on | 2015/09/05 12:59:18 |
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Basic information
Public title
Observational study of changes in endothelial micro-particles in COPD patients
Acronym
Changes in endothelial micro-particles in COPD patients
Scientific Title
Observational study of changes in endothelial micro-particles in COPD patients
Scientific Title:Acronym
Changes in endothelial micro-particles in COPD patients
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease (COPD): sable phase and acute exacerbation
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate endothelial impairment in COPD patients by measuring circulating endothelial micro-particles.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in circulating endothelial micro-particles at a stable or an acute exacerbation phase of COPD patients.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD diagnosed by spirometry
Key exclusion criteria
patients who deny participating in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Yamada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
Address
1-1 Seiryoumachi, Aobaku, Sendai JAPAN
TEL
022-717-8539
yamitsu@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Yamada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
Address
1-1 Seiryoumachi, Aobaku, Sendai JAPAN
TEL
022-717-8539
Homepage URL
yamitsu@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Red-Cross Ishinomaki Hospital
Name of secondary funder(s)
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
東北大学大学院医学系研究科（宮城県），石巻赤十字病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Blood samples
Management information
Registered date
| 2011 | Year | 03 | Month | 02 | Day |
Last modified on
| 2015 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006136
