UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000152 |
|---|---|
| Receipt number | 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 10:08:44 |
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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
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
Sponsor or person
Institute
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000221
