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

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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 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


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

Value
https://center6.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