UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003759 |
|---|---|
| Receipt number | R000004554 |
| Scientific Title | Endothelial Function Study |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2021/06/24 18:37:51 |
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Basic information
Public title
Endothelial Function Study
Acronym
Endothelial Function Study
Scientific Title
Endothelial Function Study
Scientific Title:Acronym
Endothelial Function Study
Region
| Japan |
Condition
Condition
Cardiovascular disease, Hypertension, Diabetes mellitus, Dyslipidemia, Subjects with coronary risk factors, healthy subjects
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate 1) endothelial function in ardiovascular disease, Hypertension, Diabetes mellitus, Dyslipidemia, Subjects with coronary risk factors, and healthy subjects, 2) the effects of pharmacological interventions on endothelial function
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to evaluate role of endothelial function in cardiovascular outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
endothelial function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Endothelial function
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cardiovascular diseases, hypertension, diabetes mellitus, dyslipidemia and subjects with coronary risk factors are enrolled in this study.
Key exclusion criteria
Subjects who were not able to be obtained written informed consent for participation were excluded in this study.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University Hospital
Division name
Division of Regenerative Medicine
Zip code
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5122
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima university Hospital
Division name
Division of Regenerative Medicine
Zip code
Address
1-2-3 kasumi, minamiku, hiroshima
TEL
082-257-5122
Homepage URL
http://home.hiroshima-u.ac.jp/angio/
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
This study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Science and Culture of Japan (1859081500 and 21590898).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2010 | Year | 06 | Month | 15 | 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
| 1998 | Year | 04 | Month | 01 | Day |
Date of IRB
| 1998 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 1998 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004554
| 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 |
