UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012157 |
|---|---|
| Receipt number | R000014212 |
| Scientific Title | Significance of a multiple biomarkers strategy to predict the extent of plaque burden in coronary artery disease |
| Date of disclosure of the study information | 2013/10/29 |
| Last modified on | 2013/10/29 15:16:55 |
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Basic information
Public title
Significance of a multiple biomarkers strategy to predict the extent of plaque burden in coronary artery disease
Acronym
Correlations between multiple biomarkers and coronary plaque characteristics
Scientific Title
Significance of a multiple biomarkers strategy to predict the extent of plaque burden in coronary artery disease
Scientific Title:Acronym
Correlations between multiple biomarkers and coronary plaque characteristics
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although several biomarkers and cardiovascular risk factors are implicated in coronary artery diseases, the relationships between these factors and coronary plaque morphology are not well known. The aim of this study is to correlate multiple factors with coronary plaque characteristics and sought to determine predictors of plaque morphology noninvasively. After medical treatments, the changes of multiple biomarkers and plaque will be also evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the multiple factors which predict plaque morphology noninvasively
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatient patients who receive cardiac catheterization or PCI and intracoronary imaging examinations such as IVUS, angioscopy, or OCT.
Key exclusion criteria
Patients who are considered not match this research by attending doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hirayama |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
hirayama.atsushi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuxin Li |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
li.yuxin@nihon-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukuda Foundation for Medical Technology
Organization
Division
Category of Funding Organization
Non profit foundation
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
日本大学医学部板橋病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 29 | 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
| 2011 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
1. Correlations between multiple biomarkers and coronary plaque characteristic.
2. Observe the changes of the multiple biomarkers and plaque developments during 3 years follow up.
.
Management information
Registered date
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2013 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014212
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
