UMIN-CTR Clinical Trial

Public title

LR11 time course study in patients with acute coronary syndrome

Acronym

LR11 in ACS

Scientific Title

LR11 time course study in patients with acute coronary syndrome

Scientific Title:Acronym

LR11 in ACS

Region

Japan

Condition

Patients with acute coronary syndrome and stable angina pectoris

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The evaluation of soluble LR11, a novel biomarker of smooth muscle cell in patients with acute coronary syndrome.

Basic objectives2

Others

Basic objectives -Others

Prospective observatioinal study

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Comparison of the change of LR11 value between acute coronary syndrome and stable angina pectoris.

Key secondary outcomes

The association between LR11 and coronary angiographic characterisitics

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with written informed consent of the present study

Key exclusion criteria

Hemodialysis patients
previous coronary revascularization
malignancy
inflamatory disease
Patient who judeged that examination responsibility doctor is improper as object in present study

Target sample size

150

Name of lead principal investigator

1st name	Hiroyuki
Middle name
Last name	Daida

Organization

Department of Cardiovascular Medicine, Juntendo University

Division name

Cardiovascular Medicine

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Email

daida@juntendo.ac.jp

Name of contact person

1st name	Katsumi
Middle name
Last name	Miyauchi

Organization

Department of Cardiovascular Medicine, Juntendo University

Division name

Cardiovascular Medicine

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Homepage URL

Email

ktmmy@juntendo.ac.jp

Institute

Department of Cardiovascular Medicine, Juntendo University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Department of Genome Research and Clinical Application, Chiba University, Graduate School of Medicine

Name of secondary funder(s)

Organization

Juntendo University Ethical Review Borard

Address

2-2-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-3813-3111

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Juntendo University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

07

Month

29

Day

URL releasing protocol

None

Publication of results

Unpublished

URL related to results and publications

Atherosclerosis. 2014 Nov;237(1):374-8.

Number of participants that the trial has enrolled

102

Results

The Circulating soluble LR11 levels were measured (before and at 14, 60 and 240 days after coronary stenting in a clinical study of 102 consecutive patients with stable angina pectoris who were treated with percutaneous coronary intervention. Circulating sLR11 levels were significantly increased on days 14 and 60 after the procedure and positively associated with the angiographic late loss index.

Results date posted

2021

Year

02

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

102 consecutive patients with stable angina pectoris who were treated with percutaneous coronary intervention.

Participant flow

The Circulating soluble LR11 levels were measured (before and at 14, 60 and 240 days after coronary stenting

Adverse events

None

Outcome measures

angiographic restenosis

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

07

Month

15

Day

Date of IRB

2011

Year

07

Month

15

Day

Anticipated trial start date

2011

Year

08

Month

01

Day

Last follow-up date

2012

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2013

Year

12

Month

31

Day

Other related information

LR11 is a member of the LDL receptor family and expressed specifically in intimal smooth muscle cells (SMCs) not in medial SMCs in atherosclerotic plaque.
Soluble form of LR11, which was detected in serum, has biological activity toward SMC migration.
LR11 is localized to the surfaces of smooth muscle cells. LR11 is cleaved by TNF-alfa to become a soluble form of LR11. Soluble LR11 then binds to the urokinase-type plasminogen activator receptor (uPAR) to trigger cytoskeletal reorganization and smooth muscle cell migration, which may contribute to cardiovascular disease.
The previous studies demonstrated the effect of anti-LR11 antibody on the intimal thickness of cuff injured femoral artery model in mice suggesting that LR11 plays an important role in the migration and proliferation of smooth muscle cells.
Several research studies of LR11 in human have been reported, recently.
sLR11 levels are positively correlated with IMT of carotid arteries in dyslipidemic subjects.

Registered date

2011

Year

07

Month

29

Day

Last modified on

2023

Year

08

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007188