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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027993
Receipt No. R000032058
Scientific Title Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Date of disclosure of the study information 2017/08/01
Last modified on 2019/08/11

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Basic information
Public title Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Acronym Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Scientific Title Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Scientific Title:Acronym Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Region
Japan

Condition
Condition Atherosclerosis
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison with other methods of quantitative assessment of atherosclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes An atherosclerosis coefficient based on the change with age of the diameter of the arterial blood vessel found from the moving image
Key secondary outcomes Correlations between the atherosclerosis coefficient and intima-media thickness (IMT) or cardio-ankle vascular index (CAVI)

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
7 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria None
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Morita
Organization Gifu University Graduate School of Medicine
Division name General Internal Medicine
Zip code 501-1194
Address 1-1 Yanagido, Gifu
TEL 058-230-6632
Email hmorita@gifu-u.ac.jp

Public contact
Name of contact person
1st name Takahide
Middle name
Last name Ikeda
Organization Gifu University Graduate School of Medicine
Division name General Internal Medicine
Zip code 501-1194
Address 1-1 Yanagido, Gifu
TEL 058-230-6632
Homepage URL
Email takaike@gifu-u.ac.jp

Sponsor
Institute General Internal Medicine, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Graduate School of Engineering, Gifu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Gifu University Graduate School of Medicine
Address 1-1 Yanagido, Gifu
Tel 058-230-6059
Email rinri@gifu-u.ac.jp

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 岐阜大学医学部附属病院(岐阜県)、山内ホスピタル(岐阜県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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
During data collection
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 Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 31 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 06 Month 30 Day
Date analysis concluded
2019 Year 09 Month 30 Day

Other
Other related information None

Management information
Registered date
2017 Year 06 Month 29 Day
Last modified on
2019 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032058

Research Plan
Registered date File name
2019/08/11 頸動脈エコー継続倫理審査委員会 final.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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