UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009806
Receipt number R000011492
Scientific Title Elucidation of biomarkers to predict the presence of coronary vulnerable plaque
Date of disclosure of the study information 2013/01/18
Last modified on 2020/07/25 12:21:04

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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 or person

Institute

Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011492


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name