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
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
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
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
