UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056100 |
|---|---|
| Receipt number | R000063594 |
| Scientific Title | Correlation between serum uric acid levels and atherosclerotic cardiovascular disease risk: a multivariate analysis using the Hisayama study score |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 13:56:46 |
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Basic information
Public title
Investigation of the association between serum uric acid levels and atherosclerotic cardiovascular disease risk using the Hisayama study score
Acronym
PREDICT-UA (PREvention and Detection of Cardiovascular risk: Investigating The role of Uric Acid)
Scientific Title
Correlation between serum uric acid levels and atherosclerotic cardiovascular disease risk: a multivariate analysis using the Hisayama study score
Scientific Title:Acronym
CUSHION-HART Study
Region
| Japan |
Condition
Condition
Atherosclerotic cardiovascular disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the association between serum uric acid levels and atherosclerotic cardiovascular disease (ASCVD) risk in Japanese adults. Using the prediction model based on the Hisayama Study, we seek to explore the potential of serum uric acid as a useful marker for ASCVD risk assessment and contribute to improving ASCVD prevention strategies specific to Japan.
Basic objectives2
Others
Basic objectives -Others
Quantify the correlation between serum uric acid levels and ASCVD risk in Japanese adults.
Stratify ASCVD risk based on serum uric acid quartiles and evaluate the trend.
Verify the independent association between serum uric acid levels and ASCVD risk using multivariate analysis, after adjusting for known ASCVD risk factors.
Assess the bidirectional relationship between ASCVD risk and serum uric acid levels through complementary analysis.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between serum uric acid levels and atherosclerotic cardiovascular disease (ASCVD) risk
Key secondary outcomes
Stratification analysis of ASCVD risk by serum uric acid quartiles
Independent association between serum uric acid levels and ASCVD risk after adjusting for known ASCVD risk factors
Gender differences in the association between serum uric acid levels and ASCVD risk
Correlation between serum uric acid levels and individual ASCVD risk factors (age, blood pressure, lipid profile, diabetes status, etc.)
Analysis of predictors of serum uric acid levels with ASCVD risk as an independent variable
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese adults aged 40-79 years
Underwent health check-ups between 2020 and 2022
Provided consent for study participation
Had complete data available for serum uric acid levels and ASCVD risk calculation
Key exclusion criteria
Individuals with a history of ASCVD
Individuals under 40 years old or 80 years old and above
Individuals with incomplete data for serum uric acid levels or ASCVD risk calculation
Individuals who did not provide consent for study participation
Target sample size
5984
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuyama |
Organization
Iwata City Hospital
Division name
Renal Division, Department of Internal Medicine
Zip code
438-8550
Address
512-3 Ohkubo, Iwata, Shizuoka
TEL
0538-38-5000
matsuyamatks@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuyama |
Organization
Iwata City Hospital
Division name
Renal Division, Department of Internal Medicine
Zip code
438-8550
Address
512-3 Ohkubo, Iwata, Shizuoka
TEL
0538-38-5000
Homepage URL
matsuyamatks@gmail.com
Sponsor or person
Institute
Iwata City Hospital
Institute
Department
Personal name
Funding Source
Organization
Iwata City Hospital
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
Iwata City Hospital
Address
512-3 Ohkubo, Iwata, Shizuoka
Tel
0538-38-5000
matsuyamatks@gmail.com
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 | 11 | Month | 08 | 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
5984
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063594
