UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029859 |
|---|---|
| Receipt number | R000034103 |
| Scientific Title | Screening of atherosclerosis using carotid artery flow velocity pattern |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2017/11/07 13:48:52 |
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Basic information
Public title
Screening of atherosclerosis using carotid artery flow velocity pattern
Acronym
Carotid artery flow and atherosclerosis
Scientific Title
Screening of atherosclerosis using carotid artery flow velocity pattern
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Yamada |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Community Medicine for Cardiology
Zip code
Address
2-50-1 Kuramoto Tokushima, Japan
TEL
088-633-9311
yamadah@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Yamada |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Community Medicine for Cardiology
Zip code
Address
2-50-1 Kuramoto Tokushima, Japan
TEL
088-633-9311
Homepage URL
yamadah@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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)
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
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 |
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034103
