UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013137 |
|---|---|
| Receipt number | R000013978 |
| Scientific Title | A New Noninvasive Method for Assessment of Endothelial Function: Enclosed Zone Flow-Mediated Vasodilation (New ezFMD) |
| Date of disclosure of the study information | 2014/02/12 |
| Last modified on | 2019/04/18 16:24:27 |
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Basic information
Public title
A New Noninvasive Method for Assessment of Endothelial Function: Enclosed Zone Flow-Mediated Vasodilation (New ezFMD)
Acronym
A New Noninvasive Method for Assessment of Endothelial Function: Enclosed Zone Flow-Mediated Vasodilation (New ezFMD)
Scientific Title
A New Noninvasive Method for Assessment of Endothelial Function: Enclosed Zone Flow-Mediated Vasodilation (New ezFMD)
Scientific Title:Acronym
A New Noninvasive Method for Assessment of Endothelial Function: Enclosed Zone Flow-Mediated Vasodilation (New ezFMD)
Region
| Japan |
Condition
Condition
healthy, cardiovascular disease
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the validity of ezFMD as an index of endothelial function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated the usefulness of ezFMD for assessment of endothelial function and compared the results obtained by ezFMD and conventional FMD.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
ezFMD measurement group
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy subjects, ischemic heart disease, peripheral arterial disease, hypertension, diabetes mellitus, hyperlipidemia, smoker
Key exclusion criteria
Subjects with <20 years old
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University Hospital
Division name
Division of Regeneration and Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL
082-257-5831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University Hospital
Division name
Division of Regeneration and Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL
082-257-5831
Homepage URL
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Division of Regeneration and Medicine, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Regeneration and Medicine, Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 02 | Month | 12 | 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
| 2014 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013978
