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
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
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
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
