UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012951
Receipt number R000013969
Scientific Title A multicenter study of clinical usefulness of flow-mediated vasodilation B
Date of disclosure of the study information 2014/01/24
Last modified on 2014/01/24 22:05:52

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Basic information

Public title

A multicenter study of clinical usefulness of flow-mediated vasodilation B

Acronym

FMD-J multicenter study B

Scientific Title

A multicenter study of clinical usefulness of flow-mediated vasodilation B

Scientific Title:Acronym

FMD-J multicenter study B

Region

Japan


Condition

Condition

Patients with hypertension or diabetes mellitus

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-automatec software in the risk stratification for cardiovascular diseases in Japanese subjects. In addition, there are secondary objectives, as follows: 1) to clarify whether FMD might serve as a reliable predictor of the rate of progression of carotid atherosclerosis, arterial stiffness and microalbuminuria in subjects with hypertension or diabetes mellitus, independent of the biochemical marker, including pulse-wave velocity (PWV), ankle-barchial index (ABI), serum C-reactive protein, and proteomic biomarkers; 2) to asses the relationship between biomarkers of atherosclerosis and FMD; 3) to assess the predictive value of FMD for the progression of microalbuminuria; 4) to assess the predictive value of FMD for impairment of PWV, or the predictive value of PWV for impairment of FMD.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Ultrasound examination of the carotid artery: max intima-media thickness (IMT), mean IMT. 2) Urinary microalbumin and creatinine excretion measurements.

Key secondary outcomes

Ultrasound examination of the carotid artery: plaque score


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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Enrolled patients are those with hypertension or diabetes mellitus, whose conditions are being well-controled with treatment (ie, blood pressure of <150/95 mmHg and HbA1c level of <7.5%), and who have been receiving follow-up at 1 of the participating centers for at least 6 months.

Key exclusion criteria

The exclusion criteria are: the presence of coronary artery disease, including a history of percutaneous coronary intervention or coronary bypass surgery; severe valvular heart disease; arrhythmia requiring treatment (ie, atrial fibrillation, atrial flutter, permanent pacemaker implantation or frequent ventricular premature beats); impaired left ventricular systolic function (left ventricular ejection fraction of <40%); malignancy; receiving treatment with steroids, nonsteroidal anti-inflammatory drugs or immunosuppressive drugs; a serum creatinine level of greater than 2.5 mg/dL; stroke or aortic disease (except peripheral artery disease) and serious liver disease.

Target sample size

598


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

1

Zip code


Address

1

TEL

082-257-5831

Homepage URL

https://ncsg.jp/fmdj/areserch.jsp

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=R000013969


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name