UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027993 |
|---|---|
| Receipt number | R000032058 |
| Scientific Title | Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2024/01/04 14:40:10 |
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Basic information
Public title
Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Acronym
Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Scientific Title
Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Scientific Title:Acronym
Quantitative assessment of atherosclerosis by a newly developed method with carotid ultrasonography
Region
| Japan |
Condition
Condition
Atherosclerosis
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison with other methods of quantitative assessment of atherosclerosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
An atherosclerosis coefficient based on the change with age of the diameter of the arterial blood vessel found from the moving image
Key secondary outcomes
Correlations between the atherosclerosis coefficient and intima-media thickness (IMT) or cardio-ankle vascular index (CAVI)
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
| 7 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Morita |
Organization
Gifu University Graduate School of Medicine
Division name
General Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6632
hmorita@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahide |
| Middle name | |
| Last name | Ikeda |
Organization
Gifu University Graduate School of Medicine
Division name
General Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6632
Homepage URL
takaike@gifu-u.ac.jp
Sponsor or person
Institute
General Internal Medicine, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Engineering, Gifu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@gifu-u.ac.jp
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
岐阜大学医学部附属病院（岐阜県）、山内ホスピタル（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
700
Results
To date, approximately 700 people have been measured. The analysis was conducted by dividing the subjects into two groups: a high-risk group with three or more risk factors for arteriosclerosis or a history of cardiovascular disease, and a low-risk group with fewer than three risk factors for arteriosclerosis. The slope of the relationship between actual age and vascular age was steeper in the high-risk arteriosclerosis group than in the low-risk group.
Results date posted
| 2023 | Year | 01 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because during data collection
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032058
