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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000152
Receipt No. R000000221
Scientific Title Randomized Controlled Trial to Evaluate Feasibility and Safety of Granulocyte Colony-Stimulating Factor Treatment in Patients with Acute Myocardial Infarction
Date of disclosure of the study information 2005/10/01
Last modified on 2019/02/05

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Basic information
Public title Randomized Controlled Trial to Evaluate Feasibility and Safety of Granulocyte Colony-Stimulating Factor Treatment in Patients with Acute Myocardial Infarction
Acronym Effects of G-CSF on AMI
Scientific Title Randomized Controlled Trial to Evaluate Feasibility and Safety of Granulocyte Colony-Stimulating Factor Treatment in Patients with Acute Myocardial Infarction
Scientific Title:Acronym Effects of G-CSF on AMI
Region
Japan

Condition
Condition Acute Myocardial Infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of G-CSF treatment in patients with acute myocardial infarction and successful percutaneous coronary intervention.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes between global LVEF,LVESV and LVEDV at baseline and those after 6 months follow-up
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 filgrastim 2.5microgram/kg/day x 5days
Interventions/Control_2 saline
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
80 years-old >
Gender Male and Female
Key inclusion criteria AMI patients with total coronary occulusion and successful PCI
Key exclusion criteria previous MI
persistent severe heart failure
uncontrolled myocardial ischemia
malignant disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Issei Komuro
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takano
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2005 Year 10 Month 01 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 Completed
Date of protocol fixation
2003 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 03 Month 01 Day
Last follow-up date
2005 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 09 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000221

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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