UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026978
Receipt number R000030920
Scientific Title Study on the Muse cell mobilization in patients with coronary artery disease
Date of disclosure of the study information 2018/04/01
Last modified on 2017/04/13 11:15:27

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Basic information

Public title

Study on the Muse cell mobilization in patients with coronary artery disease

Acronym

MUSE-Study

Scientific Title

Study on the Muse cell mobilization in patients with coronary artery disease

Scientific Title:Acronym

MUSE-Study

Region

Japan


Condition

Condition

Acute Myocardial Imfarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim is to examine the mobilization of Muse cells into peripheral circulating blood after acute myocardial infarction (AMI) and their effects on LV function and remodelling.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The improvement of the left ventricle (LV) function and attenuation of LV remodeling.

Key secondary outcomes

number of Muse cells, S1P concentration, LV ejection frzction, LV diastolic dimension


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Criteria is patients of AMI which defined according to the presence of prolonged anterior chest pain, ST segment elevation in electrocardiogram, and occluded coronary artery by coronary angiography.

Key exclusion criteria

Exclusion criteria is patients who judged that a doctor in attendance was unsuitable.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya Minatoguchi

Organization

Gifu University Graduate School of Medicine

Division name

Department of Cardiology

Zip code


Address

1-1 Yanagido, Gifu

TEL

058-230-6523

Email

minatos@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinya Minatoguchi

Organization

Gifu University Graduate School of Medicine

Division name

Department of Cardiology

Zip code


Address

1-1 Yanagido, Gifu

TEL

058-230-6523

Homepage URL


Email

minatos@gifu-u.ac.jp


Sponsor or person

Institute

Department of Cardiology, Gifu University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2018 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2011 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients who were admitted to Gifu University Hospital were included in this study. All subjects underwent coronary angiography and patients with over75% coronary artery stenosis were enrolled into the CAD group, whereas patients with normal coronary arteries were enrolled into the Control group. Coronary angiography was performed in the Control and CAD patients due to complaints of anterior chest pain. Diagnosis of AMI was defined based on the presence of prolonged anterior chest pain, ST segment elevation in electrocardiogram, and an occluded coronary artery by coronary angiography. AMI patients were treated with percutaneous coronary intervention followed by standard pharmacological treatment, such as anti-platelet therapy.


Management information

Registered date

2017 Year 04 Month 13 Day

Last modified on

2017 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name