UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018886 |
|---|---|
| Receipt number | R000021851 |
| Scientific Title | Clinical examination of association of circulating leukocyte subtype counts with vascular endothelial function in coronary artery disease |
| Date of disclosure of the study information | 2015/09/02 |
| Last modified on | 2015/09/03 15:57:35 |
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Basic information
Public title
Clinical examination of association of circulating leukocyte subtype counts with vascular endothelial function in coronary artery disease
Acronym
Clinical significance of circulating leukocyte subtype counts in coronary artery disease
Scientific Title
Clinical examination of association of circulating leukocyte subtype counts with vascular endothelial function in coronary artery disease
Scientific Title:Acronym
Clinical significance of circulating leukocyte subtype counts in coronary artery disease
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association of circulating leukocyte subtype counts with vascular endothelial function in coronary artery disease
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascular endothelial function, and cardiovascular events
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
coronary artery disease
Key exclusion criteria
acute coronary syndrome
severe valvular disease
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamamoto Eiichiro |
Organization
Kumamoto University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto city
TEL
096-373-5175
eyamamo@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamamoto Eiichiro |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto city
TEL
096-373-5175
Homepage URL
eyamamo@kumamoto-u.ac.jp
Sponsor or person
Institute
Dept. of Cardiovascular Medicine, Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study which examine peripheral endothelial function is measured in all study participants, and patients are prospectively followed until February 2014 or until the occurrence of cardiovascular events.
Consecutive stable patients with suspected coronary artery disease who were referred and scheduled for hospitalization at Kumamoto University Hospital between January 2008 and August 2013 for coronary angiography were registered.
Management information
Registered date
| 2015 | Year | 09 | Month | 02 | Day |
Last modified on
| 2015 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021851
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
