UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032934 |
|---|---|
| Receipt number | R000037545 |
| Scientific Title | Association of the Serum Triglyceride/high-density Lipoprotein Cholesterol Ratio with Low-density Lipoprotein Heterogeneity: A Pilot Cross-sectional and Longitudinal Study |
| Date of disclosure of the study information | 2018/06/11 |
| Last modified on | 2018/12/10 06:50:25 |
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Basic information
Public title
Association of the Serum Triglyceride/high-density Lipoprotein Cholesterol Ratio with Low-density Lipoprotein Heterogeneity: A Pilot Cross-sectional and Longitudinal Study
Acronym
TG/HDL ratio and LDL heterogeneity
Scientific Title
Association of the Serum Triglyceride/high-density Lipoprotein Cholesterol Ratio with Low-density Lipoprotein Heterogeneity: A Pilot Cross-sectional and Longitudinal Study
Scientific Title:Acronym
TG/HDL ratio and LDL heterogeneity
Region
| Japan |
Condition
Condition
patients with one additional risk factor for atherosclerosis.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed as a hospital-based cross-sectional and longitudinal study to investigate the relationships between the serum TG/HDL-C ratio and LDL-heterogeneity, as assessed by polyacrylamide-gel electrophoresis (PAGE), in patients with one or more risk factors for ACVD. Furthermore, we examined the relationship between the changes in the TG/HDL-C ratio and the change in the LDL particle size in cases in which additional measurements could also be conducted 1 year later.
Basic objectives2
Others
Basic objectives -Others
A receiver-operating characteristic analysis was performed to determine the cutoff value of the TG/HDL-C ratio for LDL-Rm values>0.40.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1)the relationships between the serum TG/HDL-C ratio and LDL-heterogeneity, as assessed by polyacrylamide-gel electrophoresis (PAGE)in patients with one or more risk factors for ACVD.
2)Furthermore, we examined the relationship between the changes in the TG/HDL-C ratio and the change in the LDL particle size in cases in which additional measurements could also be conducted 1 year later.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The criterion for patient registration in the cross sectional study was the presence of one or more risk factors for atherosclerosis.
Key exclusion criteria
Patients were not enrolled if they met any of the following exclusion criteria: presence of hepatic dysfunction (serum alanine aminotransferase and aspartate aminotransferase levels 2 times the upper limit of normal),known malignant disease, diagnosis of acute coronary syndrome within 3 months prior to the study, and/or serum TG 400 mg/dL.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Nihon University Hospital
Division name
Health Plannning Center
Zip code
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL
03-3293-1711
tanishigem@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL
03-3293-1711
Homepage URL
tanishigem@yahoo.co.jp
Sponsor or person
Institute
Department of Health Planning Center, Nihon-University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Health Planning Center, Nihon-University 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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 07 | Month | 30 | Day |
Other
Other related information
This study was designed as a hospital-based cross-sectional and longitudinal study to investigate the relationships between the serum TG/HDL-C ratio and LDL-heterogeneity, as assessed by polyacrylamide-gel electrophoresis (PAGE), in patients with one or more risk factors for ACVD. Furthermore, we examined the relationship between the changes in the TG/HDL-C ratio and the change in the LDL particle size in cases in which additional measurements could also be conducted 1 year later.
Management information
Registered date
| 2018 | Year | 06 | Month | 09 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037545
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
