BACKGROUND: Early clinical studies have suggested that administration of granulocyte-colony stimulating factor (G-CSF) may improve the clinical condition of patients suffering from myocardial infarction (MI).This prospective, randomized, double-blind, placebo-controlled single-centre trial aims to assess the safety and clinical efficacy of G-CSF administration in patients with subacute MI and impaired LV functionundergoing delayed primary percutaneous coronary intervention (PCI). METHODS: A total of 16 patients (13 men, mean age 51 years) with subacute ST-segment elevation MI and a left ventricular (LV) ejection fraction (EF) of less than 45% at baseline who underwent late revascularization, were included in the study. Patients were randomized in a double-blind fashion to receive either G-CSF (at a dose of 10 microg/kg body weight) or placebo for five consecutive days. End points consisted of assessment of safety parameters as well as changes of global and regional myocardial function from baseline until six months following PCI. RESULTS:G-CSF administration resulted in a significant mobilization of different cell populations (four-fold increase in WBC count and a six-fold increase in CD34+ cells). G-CSF treatment was well tolerated in most patients and no major adverse cardiac events or severe G-CSF-related side effects were identified during hospitalization and at follow-up. No significant differences were observed between the G-CSF and placebo groups regarding global and regional myocardial function parameters. CONCLUSION:G-CSF administration is safe, but not effective, in improving impaired LV functional parameters in patients with subacute MI who had an impaired baseline EF of less than 45%.
RCT Entities:
BACKGROUND: Early clinical studies have suggested that administration of granulocyte-colony stimulating factor (G-CSF) may improve the clinical condition of patients suffering from myocardial infarction (MI).This prospective, randomized, double-blind, placebo-controlled single-centre trial aims to assess the safety and clinical efficacy of G-CSF administration in patients with subacute MI and impaired LV function undergoing delayed primary percutaneous coronary intervention (PCI). METHODS: A total of 16 patients (13 men, mean age 51 years) with subacute ST-segment elevation MI and a left ventricular (LV) ejection fraction (EF) of less than 45% at baseline who underwent late revascularization, were included in the study. Patients were randomized in a double-blind fashion to receive either G-CSF (at a dose of 10 microg/kg body weight) or placebo for five consecutive days. End points consisted of assessment of safety parameters as well as changes of global and regional myocardial function from baseline until six months following PCI. RESULTS:G-CSF administration resulted in a significant mobilization of different cell populations (four-fold increase in WBC count and a six-fold increase in CD34+ cells). G-CSF treatment was well tolerated in most patients and no major adverse cardiac events or severe G-CSF-related side effects were identified during hospitalization and at follow-up. No significant differences were observed between the G-CSF and placebo groups regarding global and regional myocardial function parameters. CONCLUSION:G-CSF administration is safe, but not effective, in improving impaired LV functional parameters in patients with subacute MI who had an impaired baseline EF of less than 45%.