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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018100
Receipt No. R000020948
Scientific Title Confirmatory study of high resolution ultrasound imaging of the carotid artery using frequency domain interferometry
Date of disclosure of the study information 2015/07/01
Last modified on 2018/09/29

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Basic information
Public title Confirmatory study of high resolution ultrasound imaging of the carotid artery using frequency domain interferometry
Acronym Confirmatory study of high resolution ultrasound imaging
Scientific Title Confirmatory study of high resolution ultrasound imaging of the carotid artery using frequency domain interferometry
Scientific Title:Acronym Confirmatory study of high resolution ultrasound imaging
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the performance of the high-resolution method for carotid artery imaging.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate the performance of the high-resolution method in depicting arterial wall of human carotid artery.
Key secondary outcomes We compare the carotid intima-media thickness and the blood test values.
We investigate the performance of the ultrasound elastography imaging method for carotid artery.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Acquiring the ultrasound image of carotid artery.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Inpatients of Department of Diabetes and Clinical Nutrition, Kyoto University, with diabetes mellitus type 1 or 2.
2) The age of a patient ranges from 20 to 80 at the registration.
3) The patient gives a written consent to participate in this study.
Key exclusion criteria 1) Patient with a cardiac pacemaker.
2) Patient receiving total parenteral nutrition.
3) Patient with stents at both of the carotid arteries.
4) Patient with carotid endarterectomy at both of the carotid arteries.
5) Patient with walking difficulty.
6) Pregnant woman, woman who has a possibility to be pregnant, and woman at lactation period.
7) Patient who is inappropriate to this study, judged by the lead principal investigator or the doctor in attendance.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Shiina
Organization Kyoto University
Division name Graduate School of Medicine
Zip code
Address 53, Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-4998
Email shiina.tsuyoshi.6w@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Sato
Organization Kyoto University
Division name Graduate School of Informatics
Zip code
Address Yoshida-honmachi, Sakyo-ku, Kyoto 606-8501, Japan
TEL 075-753-3365
Homepage URL
Email sato.toru.6e@kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Innovative Techno-Hub for Integrated Medical Bio-imaging Project of the Special Coordination Funds for Promoting Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tohoku University
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2015 Year 07 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
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
2015 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 26 Day
Last modified on
2018 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020948

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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