UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027504 |
|---|---|
| Receipt number | R000031523 |
| Scientific Title | Clinical utility of a small dense LDL cholesterol measurement reagent in coronary artery disease (CAD) |
| Date of disclosure of the study information | 2017/05/26 |
| Last modified on | 2024/06/05 11:24:30 |
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Basic information
Public title
Clinical utility of a small dense LDL cholesterol measurement reagent in coronary artery disease (CAD)
Acronym
Clinical utility of a small dense LDL cholesterol measurement reagent in coronary artery disease (CAD)
Scientific Title
Clinical utility of a small dense LDL cholesterol measurement reagent in coronary artery disease (CAD)
Scientific Title:Acronym
Clinical utility of a small dense LDL cholesterol measurement reagent in coronary artery disease (CAD)
Region
| Japan |
Condition
Condition
coronary artery disease (CAD)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives are: to examine, using frozen serum, the association between measurements of sdLDL-C by homogenous assay and the course of coronary artery disease; and to market an sdLDL-C measurement reagent as an in vitro diagnostic.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between clinical information and clinical course 10 years after blood collection.
Key secondary outcomes
We will group sdLDL-C values by sex and concentration to examine their associations with coronary lesion severity and cardiovascular events over 10 years in order to determine the blood concentrations of sdLDL-C associated with varying degrees of coronary artery disease severity. We will also compare values of LDL-C and non-HDL cholesterol.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Coronary artery disease patients who have undergone cardiac catheterization at Showa University Hospital
Key exclusion criteria
none
Target sample size
3625
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Koba |
Organization
Showa University
Division name
Division of Cardiology, Department of Medicine, School of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL
03-3784-8000
skoba@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Koba |
Organization
Showa University
Division name
Division of Cardiology, Department of Medicine, School of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL
03-3784-8000
Homepage URL
skoba@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
DENKA SEIKEN Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Diabetes and Endocrinology, Department of Internal Medicine, School of Medicine
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
昭和大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031523
