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Recruitment status
Unique ID issued by UMIN UMIN000001987
Receipt No. 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

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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
Email

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
Email

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

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002375

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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