UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021748 |
|---|---|
| Receipt number | R000024608 |
| Scientific Title | Evaluation of the relationship between earlobe crease and endothelial function |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2024/04/08 16:44:58 |
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Basic information
Public title
Evaluation of the relationship between earlobe crease and endothelial function
Acronym
Earlobe Crease and Flow-mediated Vasodilation Study (ELC/FMD study)
Scientific Title
Evaluation of the relationship between earlobe crease and endothelial function
Scientific Title:Acronym
Earlobe Crease and Flow-mediated Vasodilation Study (ELC/FMD study)
Region
| Japan |
Condition
Condition
healthy subjects, hypertension, diabetes mellitus, hyperlipidemia, peripheral arterial disease, myocardial infarction, stroke, heart failure, renal failure, smoker
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between ELC and endothelail function and to consider whether ELC is a predictor of atherosclerosis or not.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to investigate the relationship between ELC and other vascular function.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow-mediated vasodiation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Assessment of earlobe crease and of vascular function in healthy subjects and patients with atherosclerosis
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy subjects, hypertension, diabetes mellitus, dyslipidemia, peripheral arterial disease, myocardial infarction, stroke, heart failure, renal failure, atherosclerosis, smoker
Key exclusion criteria
Subjects without informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima University Hospital
Division name
Department of Cardiovascular Regeneration and Medicine
Zip code
734-8553
Address
1-2-3kasumi, minamiku, hiroshima
TEL
+81-82-257-5831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima University Hospital
Division name
Department of Cardiovascular Regeneration and Medicine
Zip code
734-8553
Address
1-2-3kasumi, minamiku, hiroshima
TEL
+81-82-257-5831
Homepage URL
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Regeneration and Medicine, Hiroshima 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
Hiroshima University Ethics Review Committee
Address
1-2-3kasumi, minamiku, hiroshima
Tel
+81-82-257-5907
kasumi-kenkyu@office.hiroshima-u.ac.jp
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
| 2016 | Year | 04 | Month | 01 | 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
| 2015 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the relationship between ELC and FMD
Management information
Registered date
| 2016 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024608
