UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012952
Receipt number 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 22:10:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

FMD Japan

Institute

Department

Personal name



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

Value
https://center6.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