UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053345 |
|---|---|
| Receipt number | R000060877 |
| Scientific Title | Analysis of the association between LOX-index and arteriosclerosis detailed examination in recipients of general check-up |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2025/01/15 08:01:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of the association between LOX-index and arteriosclerosis detailed examination in recipients of general check-up
Acronym
Analysis of the association between LOX-index and arteriosclerosis detailed examination in recipients of general check-up
Scientific Title
Analysis of the association between LOX-index and arteriosclerosis detailed examination in recipients of general check-up
Scientific Title:Acronym
Analysis of the association between LOX-index and arteriosclerosis detailed examination in recipients of general check-up
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Arteriosclerotic diseases account for approximately 23% of causes of death in Japan, which is almost the same as malignant neoplasms. It is also considered to be the main factor causing the discrepancy between average life expectancy and healthy life expectancy, and the search for optimal arteriosclerotic disease predictive factors (biomarkers) in health checkups is extremely important. By simultaneously measuring the detailed arteriosclerosis examination which we have already conducted at our hospital, and LOX-index (arteriosclerosis disease onset risk test), we aim to explore the relationship between the two and develop a new arteriosclerosis prediction model.
Basic objectives2
Others
Basic objectives -Others
Exploring the relationship between arteriosclerosis onset and LOX-index
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
LOX-index, arteriosclerosis detailed examination items (MDA-LDL, lipoprotein (a), RLP cholesterol, apoprotein (A-I, B, E))
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons over 18 years of age
2. Those who have received sufficient explanation and have freely given their written consent to participate in this research.
Key exclusion criteria
A person who is judged to be inappropriate by the research director or co-partner.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nishizaki |
Organization
Tokai University School of Medicine
Division name
Department of Clinical Health Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463931121
y-nishizaki@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Kishimoto |
Organization
Tokai University School of Medicine
Division name
Department of Clinical Health Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463931121
Homepage URL
n-kissy@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
PreMedica Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
Tel
0463-93-1121
tokai-rec@tsc.u-tokai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 01 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060877
