UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027571 |
|---|---|
| Receipt number | R000031031 |
| Scientific Title | Study on the relationship between a new measure of high-density lipoprotein (HDL) functionlity and clinical prognosis in patients after coronary artery stent implantation |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/05/31 16:50:54 |
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Basic information
Public title
Study on the relationship between a new measure of high-density lipoprotein (HDL) functionlity and clinical prognosis in patients after coronary artery stent implantation
Acronym
Study on the relationship between a new measure of high-density lipoprotein (HDL) functionlity and clinical prognosis in patients after coronary artery stent implantation
Scientific Title
Study on the relationship between a new measure of high-density lipoprotein (HDL) functionlity and clinical prognosis in patients after coronary artery stent implantation
Scientific Title:Acronym
Study on the relationship between a new measure of high-density lipoprotein (HDL) functionlity and clinical prognosis in patients after coronary artery stent implantation
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the risk factors on clinical prognosis in HDL function and OCT findings of patients after stent implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the relationship between HDL function and target lesion revascularization
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with stent implantation who underwent OCT follow-up and evaluate HDL function during the period from April 2011 to March 2015
Key exclusion criteria
1) anatomically unsuitable target artery for OCT
2) apparent congestive heart failure
3) renal insufficiency with baseline creatinine level > 2.0 mg/dl except for under hemodialysis
4) no written informed consent from the patient
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Otake |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan
TEL
078-382-5846
hiromasaotake743@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Nagano |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan
TEL
078-382-5846
Homepage URL
y_nagano1981@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine
Kobe University Graduate School of Medicine
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
| 2017 | Year | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have nothing particular to report.
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031031
