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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006075
Receipt No. R000007188
Scientific Title LR11 time course study in patients with acute coronary syndrome
Date of disclosure of the study information 2011/07/29
Last modified on 2015/07/29

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Basic information
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
Condition Patients with acute coronary syndrome and stable angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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 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

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Daida
Organization Department of Cardiovascular Medicine, Juntendo University
Division name Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email daida@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumi Miyauchi
Organization Department of Cardiovascular Medicine, Juntendo University
Division name Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email ktmmy@juntendo.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Juntendo University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Genome Research and Clinical Application, Chiba University, Graduate 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 Juntendo University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 29 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 Preinitiation
Date of protocol fixation
2011 Year 07 Month 15 Day
Date of IRB
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
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.

Management information
Registered date
2011 Year 07 Month 29 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007188

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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