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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012157
Receipt No. 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

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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
Email 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
Email li.yuxin@nihon-u.ac.jp

Sponsor
Institute Division of Cardiovascular, Nihon University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014212

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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