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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015635
Receipt No. 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

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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
Last 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
Email norikiyo.oka@ma.point.ne.jp

Public contact
1st 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
Email norikiyo.oka@ma.point.ne.jp

Sponsor
Institute Chiba University graduate school of medicine
Institute
Department

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
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 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
URL(English) https://upload.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


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