UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Screening of atherosclerosis using carotid artery flow velocity pattern
Title of the study (Brief title)	Carotid artery flow and atherosclerosis
Region	Japan

Condition
Condition	Atherosclerosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Carotid artery blood flow velocity is recorded using ultrasonic Doppler equipment in patients with atherosclerotic risk factors. We are looking for indicators which reflect the degree of atherosclerosis among the parameters obtained from the carotid artery blood flow velocity pattern. We also are testing efficacy and safety of simple ultrasonic Doppler recording device specialized for detection of carotid arterial blood flow waveform (developed by the Department of Social Industry Science and Engineering, The University of Tokushima Graduate School of Science and Technology).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Parameters obtained from the carotid artery blood flow velocity pattern
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Carotid artery blood flow velocity waveform is recording using a simple ultrasonic Doppler recording device developed by the Institute of Social Industry Science and Engineering, the University of Tokushima Graduate School.
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	30 patients with lifestyle-related diseases who visited the University of Tokushima university hospital between September 2017 and March 2018 and were referred to perform diagnostic ultrasound examination of the carotid artery for clinical purposes.
Key exclusion criteria	1) Severe carotid artery lesion (including after stent implantation, and after endarterectomy) 2) Patients who did not obtain consent
Target sample size	30

Research contact person
Name of lead principal investigator	Hirotsugu Yamada
Organization	Tokushima University Graduate School of Biomedical Sciences
Division name	Community Medicine for Cardiology
Address	2-50-1 Kuramoto Tokushima, Japan
TEL	088-633-9311
Email	yamadah@tokushima-u.ac.jp

Public contact
Name of contact person	Hirotsugu Yamada
Organization	Tokushima University Graduate School of Biomedical Sciences
Division name	Community Medicine for Cardiology
Address	2-50-1 Kuramoto Tokushima, Japan
TEL	088-633-9311
Homepage URL
Email	yamadah@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization	Chunichi-suwa opto electrical
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Faculty of Science and Technology, Tokushima University
Name of secondary funｄer(s)

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	徳島大学病院（徳島県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 10 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 07 Day
Last modified on	2017 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034103