UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026795
Receipt number R000030750
Scientific Title Ultrasound diagnosis of carotid arterial atherosclerosis using phased tracking method
Date of disclosure of the study information 2017/04/01
Last modified on 2017/03/31 09:06:05

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Basic information

Public title

Ultrasound diagnosis of carotid arterial atherosclerosis using phased tracking method

Acronym

Diagnosis of atherosclerosis using phase tracking method of untrasound

Scientific Title

Ultrasound diagnosis of carotid arterial atherosclerosis using phased tracking method

Scientific Title:Acronym

Diagnosis of atherosclerosis using phase tracking method of untrasound

Region

Japan


Condition

Condition

Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether the elasticiy of carotid artery measured using ultrasound phased tracking method associated with risk factors of atherosclerosis.

Basic objectives2

Others

Basic objectives -Others

To evaluate the association between the extent of atherosclerosis and risk factors.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cross sectional study.
The association of the elasticiy of carotid artery measured using ultrasound phased tracking method and atherosclerotic risk factors (age, gender, blood pressure, glucose, lipid, kidney function, etc.).

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients having medical care at Department of Metabolism and Diabetes, Tohoku University Hospital.

Key exclusion criteria

Patients whose doctor do not agree to participate the study.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Katagiri

Organization

Tohoku University Hospital

Division name

Department of Metabolism and Diabetes

Zip code


Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

TEL

022-717-7611

Email

katagiri@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shojiro Sawada

Organization

Tohoku University Hospital

Division name

Department of Metabolism and Diabetes

Zip code


Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

TEL

022-717-7611

Homepage URL


Email

ssawada@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Hospital

Organization

Division

Category of Funding Organization

Self funding

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

2017 Year 04 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

2011 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study
To investigate the association between carotid arterial elasticity and risk factors of atherosclerosis, such as age, gender, blood pressure, glucose, lipids and kidney functions, we will analyse the cross sectional study.


Management information

Registered date

2017 Year 03 Month 31 Day

Last modified on

2017 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030750


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name