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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026795
Receipt No. 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

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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
Institute Tohoku University Hospital
Institute
Department

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
URL(English) https://upload.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


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