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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003409
Receipt No. R000004131
Scientific Title Flow-Mediated vasoDilation (FMD) Study
Date of disclosure of the study information 2010/04/01
Last modified on 2010/03/30

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Basic information
Public title Flow-Mediated vasoDilation (FMD) Study
Acronym FMD Study
Scientific Title Flow-Mediated vasoDilation (FMD) Study
Scientific Title:Acronym 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
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to measure FMD in general population, including healthy subjects and patients with vascular diseases and to determine the predictors for FMD.
Basic objectives2 Others
Basic objectives -Others To determine the predictors for FMD.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes FMD
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 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 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihito Higashi
Organization Hiroshima University Graduate School of Biomedical Sciences
Division name Department of cardiovascular physiology and medicine
Zip code
Address 1-2-3kasumi, minamiku, hiroshima
TEL 082-257-5122
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukihito Higashi
Organization Hiroshima university graduate school of biomedical science
Division name Department of cardiovascular physiology and medicine
Zip code
Address 1-2-3kasumi, minamiku, hiroshima
TEL 082-257-5122
Homepage URL
Email yhigashi@hiroshima-u.ac.jp

Sponsor
Institute Department of Cardiovascular Physiology and Medicine, Hiroshima University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Ministry of Education, Sciences and Culture
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
Email

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 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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 To determine whether FMD is a predictor of vascular events.

Management information
Registered date
2010 Year 03 Month 30 Day
Last modified on
2010 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004131

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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