UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015635 |
|---|---|
| Receipt number | R000018173 |
| Scientific Title | Evaluation of plaque luminance change by using optical coherence tomography and intracoronary administration of microbubble contrast agent |
| Date of disclosure of the study information | 2014/11/10 |
| Last modified on | 2016/11/09 15:13:06 |
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Basic information
Public title
Evaluation of plaque luminance change by using optical coherence tomography and intracoronary administration of microbubble contrast agent
Acronym
Evaluation of plaque luminance change by using optical coherence tomography and intracoronary administration of microbubble contrast agent
Scientific Title
Evaluation of plaque luminance change by using optical coherence tomography and intracoronary administration of microbubble contrast agent
Scientific Title:Acronym
Evaluation of plaque luminance change by using optical coherence tomography and intracoronary administration of microbubble contrast agent
Region
| Japan |
Condition
Condition
coronary artery disease after stent implantation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relation between plaque progression and neovascularization after stent implantation by analyzing and quantifying the change of plaque luminance, using optical coherence tomography with intracoronary administration of microbubble contrast agent.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plaque progression and luminance, neovascularization after stent implantation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who plan to have follow-up coronary angiography after stent implantation
Key exclusion criteria
Patients who are allergic to contrast Sonazoid or egg, who are pregnant or suspected of pregnancy, who have kidney dysfunction, or patients whom doctor considers inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University graduate school of medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture
TEL
043-222-7171
norikiyo.oka@ma.point.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikiyo Oka |
Organization
Chiba University graduate school of medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture
TEL
043-222-7171
Homepage URL
norikiyo.oka@ma.point.ne.jp
Sponsor or person
Institute
Chiba University graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University graduate school of medicine
Organization
Division
Category of Funding Organization
Self funding
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 10 | 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
| 2013 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
To evaluate the relation between plaque progression and neovascularization after stent implantation by analyzing and quantifying the change of plaque luminance, using optical coherence tomography with intracoronary administration of microbubble contrast agent.
Management information
Registered date
| 2014 | Year | 11 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018173
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/11/09 | OCTバブル計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/11/09 | OCTバブル計画書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
