UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the relationship between a new measure of high-density lipoprotein (HDL) functionlity and clinical prognosis in patients after coronary artery stent implantation
Title of the study (Brief 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
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	Hiromasa Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
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	Yuichiro Nagano
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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