UMIN-CTR Clinical Trial

Public title

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

Acronym

FMD-J multicenter study A

Scientific Title

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

Scientific Title:Acronym

FMD-J multicenter study A

Region

Japan

Condition

Patients with coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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 assess the predictive value of FMD for future cardiovascular events in Japanese subjects with coronary artery disease, independent of the conventional risk factors for cardiovascular disease; 2) to evaluate the usefulness of a multimarker strategy, including measurements of FMD, pulse-wave velocity (PWV), ankle-brachial index (ABI), biochemical markers (serum C-reactive protein, oxidized low-density lipoprotein cholesterol, and plasma B-type natriuretic peptide levels) and a proteomic biomarker identified by mass-spectroscopic analysis, to assess the prognosis of Japanese subjects with coronary artery disease.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The present study has 2 primary composite endpoints; the first was coronary artery restenosis or de novo coronary artery stenosis as confirmed by diagnostic imaging (ie, coronary angiography, coronary computed tomography, or radioisotope scintigraphy) either with or without the clinical symptoms of fatal or nonfatal myocardial infarction; second was stroke or heart failure and sudden death.

Key secondary outcomes

The secondary endpoints include each of the 2 primary endpoints plus recurrence of angina pectoris without confirmation by diagnostic imaging (ie, confirmed by symptom self-reports only), newly diagnosed aortic diseases (aneurysm or dissection) as confirmed by diagnostic imaging, newly diagnosed peripheral arterial disease as confirmed by an ABI of less than 0.9, and malignancy or death.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Enrolled patients are those with diagnosis of coronary artery disease, with the number of diseased arteries determined by either coronary angiography, cardiac nuclear scintigraphy, or coronary CT and who have been under regular follow-up at any of the participating centers for at least 6 months.

Key exclusion criteria

A history of coronary bypass surgery; severe valvular heart disease; arrhythmia which requires treatment (ie, atrial fibrillation, atrial flutter, permanent pacemaker implantation or frequent ventricular premature beats); severe chronic heart failure (a New York Heart Association level of greater than Level III); malignancy; current receiving treatment with steroids, nonsteroidal anti-inflammatory drugs or immunosuppressive drugs; a serum creatinine level greater than 2.5 mg/dL; a history of stroke or aortic disease, and serious liver disease.

Target sample size

642

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

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

Institute

FMD Japan

Institute

Department

Personal name

Organization

FMD Japan

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Observational study

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=R000013964