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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012952
Receipt No. R000013999
Scientific Title A multicenter study of clinical usefulness of flow-mediated vasodilation C
Date of disclosure of the study information 2014/01/24
Last modified on 2014/01/24

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Basic information
Public title A multicenter study of clinical usefulness of flow-mediated vasodilation C
Acronym FMD-J multicenter study C
Scientific Title A multicenter study of clinical usefulness of flow-mediated vasodilation C
Scientific Title:Acronym FMD-J multicenter study C
Region
Japan

Condition
Condition Healthy subjects, or patients with cardiovascular risk factor or established cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to establish the usefulness of FMD as measured by online semi-automatic software in the risk stratification for cardiovascular diseases in Japanese subjects. In addition, the secondary objective was to assess the relationships between FMD and other cardiovascular risk markers, including pulse-wave velocity (PWV), ankle-brachial index (ABI), serum C-reactive protein, proteomic biomarkers, carotid atherosclerosis, arterial stiffness, and micaroalbuminuria.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) FMD, 2) PWV, ABI, serum C-reactive protein, proteomic biomarkers, ultrasound examination of the carotid artery [max intima-media thickness (IMT), mean IMT], arterial stiffness, and micaroalbuminuria.
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 The study subjects are employees of an electronics and chemical company who undergo annual health checkups mandated by the company.
Key exclusion criteria none
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yamashina
Organization Tokyo Medical University
Division name Second Department ofINternal Medicine
Zip code
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Email akyam@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihito Higashi
Organization Research Institute for Radiation Biology and Medicine
Division name Department of Cardiovascular Regeneration and Medicine
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL 082-257-5831
Homepage URL
Email yhigashi@hiroshima-u.ac.jp

Sponsor
Institute FMD Japan
Institute
Department

Funding Source
Organization FMD Japan
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
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
2014 Year 01 Month 24 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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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 Observational study

Management information
Registered date
2014 Year 01 Month 24 Day
Last modified on
2014 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013999

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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