Clinical trial for effectiveness and safety of granulocyte colony-stimulating factor treatment in patients with acute myocardial infarction

UMIN ID: UMIN000001987

Registered date:21/05/2009

Basic Information

• Health condition(s) or Problem(s) studied: Acute Myocardial Infarction
• Date of first enrollment: 2009/01/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

G-CSF treatment
Placebo treatment

Outcome(s)

• Primary Outcome: reduction of infarct area
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Cardiovascular Science and Medicine Chiba University Graduate School of Medicine
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare