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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027571
Receipt No. 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

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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
Email 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
Email y_nagano1981@yahoo.co.jp

Sponsor
Institute Division of Cardiovascular Medicine
Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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