UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001987 |
|---|---|
| Receipt number | R000002375 |
| Scientific Title | Clinical trial for effectiveness and safety of granulocyte colony-stimulating factor treatment in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2009/05/21 |
| Last modified on | 2009/05/21 02:31:06 |
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Basic information
Public title
Clinical trial for effectiveness and safety of granulocyte colony-stimulating factor treatment in patients with acute myocardial infarction
Acronym
G-CSF treatment for left ventricular dysfunction after AMI (GLEAM-2)
Scientific Title
Clinical trial for effectiveness and safety of granulocyte colony-stimulating factor treatment in patients with acute myocardial infarction
Scientific Title:Acronym
G-CSF treatment for left ventricular dysfunction after AMI (GLEAM-2)
Region
| Japan |
Condition
Condition
Acute Myocardial Infarction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this clinical trial is to evaluate effectiveness and safety of G-CSF against cardiac remodeling after acute myocardial infarction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
reduction of infarct area
Key secondary outcomes
inhibition of cardiac remodeling after MI
inhibition of cardiac dysfunction after MI
reduction of cardiovascular event, such as cardiac sudden death, non-fatal MI, unstable angina, hospital admission due to heart failure, and lethal arrhythmia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
G-CSF treatment
Interventions/Control_2
Placebo treatment
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients were eligible if they were admitted within 12 h after onset of AMI with total occlusion of single coronary artery and underwent successful PCI.
Diagnosis of AMI was achieved with continuous chest pain over 30 min, and/or ST elevation over 0.1mV in more than 2 extremity leads, and/or ST elevation over 0.2mV in more than 2 chest leads
Key exclusion criteria
1) Patients who have uncontrolled myocardial ischemia after PCI
2) Patients who ara suspected to have acute coronary occlusion
3) Patients who are in cardiac shock
4) Patients who have malignant diseases
5) Patients who have diabetic retinopathy
6) Patients who have severe drug allergy
7) When informed concent is not obtained from patients
8) When doctors decide that patients do not have eligibility for this study
Target sample size
100
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 260-8670, Japan
TEL
043-226-2555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takano |
Organization
Chiba University Hospital
Division name
Departmento of Cardiology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2555
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
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 05 | Month | 21 | 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
Date of protocol fixation
| 2008 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | 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
| 2009 | Year | 05 | Month | 21 | Day |
Last modified on
| 2009 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002375
