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

Email

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


Email

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


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

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