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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025149
Receipt No. R000028919
Scientific Title Development of Integrated Backscatter Intravascular Ultrasound with 60MHz Ultrasound Signals
Date of disclosure of the study information 2016/12/05
Last modified on 2018/12/05

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Basic information
Public title Development of Integrated Backscatter Intravascular Ultrasound with 60MHz Ultrasound Signals
Acronym VISICUBE IB-IVUS Study
Scientific Title Development of Integrated Backscatter Intravascular Ultrasound with 60MHz Ultrasound Signals
Scientific Title:Acronym VISICUBE IB-IVUS Study
Region
Japan

Condition
Condition Coronary Heart Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of integrated backscatter intravascular ultrasound with 60MHz unltasound signals
Basic objectives2 Others
Basic objectives -Others Comparison between images obtained with 40MHz and 60MHz ultrasound singnals
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Setting thresholds of integrated backscatter values
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with coronary heart disease that required percutaneous coronary interventions
Key exclusion criteria Patients with serum creatinin more than 1.5mg/dl
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Kawasaki
Organization Gifu University Hospital
Division name Department of Cardiology
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6523
Email masanori@ya2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Kawasaki
Organization Gifu University Hospital
Division name Department of Cardiology
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6523
Homepage URL
Email masanori@ya2.so-net.ne.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization TERUMO Corp.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 05 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
2016 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Secondary use of obtained data: none

Management information
Registered date
2016 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028919

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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