UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of biomarkers to predict the presence of coronary vulnerable plaque
Acronym	Prediction of vulnerable plaque by biomarkers
Scientific Title	Elucidation of biomarkers to predict the presence of coronary vulnerable plaque
Scientific Title:Acronym	Prediction of vulnerable plaque by biomarkers
Region	Japan

Condition
Condition	Patients with coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Rupture of vulnerable plaque (VP) with thrombus formation is the main mechanism of acute coronary syndrome. Furthermore, percutaneous coronary intervention (PCI) to VP is associated with distal embolism and reperfusion injury. However, the methods predicting the presence of VP have not been established. The aim of this study is to determine the useful biomarkers to predict VP existence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To establish biomarkers associated with the presence of VP
Key secondary outcomes	1. Prediction of peri-procedural myocardial injury by biomarkers and intracoronary imaging modality 2. To evaluate the association between biomarkers and indices of vascular function 3. Prediction of VP by the combination of biomarkers and intracoronary imaging modality

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients or suspected patients with coronary artery disease who admit to our hospital for cardiac catheterization or PCI
Key exclusion criteria	1. Patients with end-stage renal disease without hemodialysi 2. Patients with bleeding risk or hemostatic disorder 3. Patients with anemia 4. Patients with contrast media allergy 5. Patients with the potential difficulty in manipulation of catheter
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koji Maemura
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Cardiovascular Medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Cardiovascular Medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 18 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	Completed
Date of protocol fixation	2012 Year 06 Month 08 Day
Date of IRB	2012 Year 06 Month 08 Day
Anticipated trial start date	2012 Year 06 Month 08 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1. To evaluate the significance of biomarkers among different types of coronary artery diseases including stable angina pectoris and acute coronary syndrome. 2. To evaluate the significance of biomarkers among different characteristics of coronary plaques including fibrotic, lipidic, and vulnerable plaque observed by intracoronary imaging modality. 3. To evaluate the changes of values of biomarkers before and after PCI. 4. To evaluate the significance of biomarkers in patients with and without peri-procedual myocardial injury. 5. To compare the biomarkers with indices of endothelial function and atherosclerosis.

Management information
Registered date	2013 Year 01 Month 18 Day
Last modified on	2020 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011492