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
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
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=R000013969
