UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009281 |
|---|---|
| Receipt number | R000010885 |
| Scientific Title | Analysis of the effects of HDL function in coronary artery disease and search of a new target for the treatment of arteriosclerosis |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2015/07/04 12:10:28 |
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Basic information
Public title
Analysis of the effects of HDL function in coronary artery disease and search of a new target for the treatment of arteriosclerosis
Acronym
Analysis of HDL function
Scientific Title
Analysis of the effects of HDL function in coronary artery disease and search of a new target for the treatment of arteriosclerosis
Scientific Title:Acronym
Analysis of HDL function
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify miR-33a and miR33-b related to the quantity and quality of high-density lipoprotein cholesterol (HDL-C) is how the development of coronary artery disease and more developing the treatment of coronary artery disease by improving functions of HDL-C.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. plaque volume changes,concentration and function of HDL-C from baseline to follow up.
2. association of quantity of miR-33a and miR-33b with functions of HDL-C
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Two hundred consecutive patients underwent PCI
Key exclusion criteria
Patients who can not enforce follow up CAG and IVUS.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Takeshi |
Organization
Kyoto University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
Shougoinkawaharamachi 54 Sakyouku Kyoto
TEL
075-751-4255
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Imai Masao |
Organization
Kyoto University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
Shougoinkawaharamachi 54 Sakyouku Kyoto
TEL
075-751-4254
Homepage URL
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
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
| 2012 | Year | 12 | 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
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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Factors and findings to examine the relevance:
Factor:Clinical parameter, lipid profiles and qualitative features of HDL-C
Result:Development of coronary artery disease
Prospective study
Case control sampling
Management information
Registered date
| 2012 | Year | 11 | Month | 07 | Day |
Last modified on
| 2015 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010885
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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