UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018100 |
|---|---|
| Receipt number | 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 20:27:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sato.toru.6e@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020948
