UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the Muse cell mobilization in patients with coronary artery disease
Title of the study (Brief title)	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	Shinya Minatoguchi
Organization	Gifu University Graduate School of Medicine
Division name	Department of Cardiology
Address	1-1 Yanagido, Gifu
TEL	058-230-6523
Email	minatos@gifu-u.ac.jp

Public contact
Name of contact person	Shinya Minatoguchi
Organization	Gifu University Graduate School of Medicine
Division name	Department of Cardiology
Address	1-1 Yanagido, Gifu
TEL	058-230-6523
Homepage URL
Email	minatos@gifu-u.ac.jp

Sponsor
Institute	Department of Cardiology, Gifu University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030920