UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012950 |
|---|---|
| Receipt number | R000013964 |
| Scientific Title | A multicenter study of clinical usefulness of flow-mediated vasodilation A |
| Date of disclosure of the study information | 2014/01/24 |
| Last modified on | 2014/01/24 21:57:28 |
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Basic information
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
Condition
Patients with coronary artery 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-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
Assessment
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.
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 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
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
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
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
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=R000013964
