The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF).
This clinical study is a phase II randomized trial for patients with an acute extensive reperfunded myocardial infarction who undergo coronary artery revascularization with sirolimus coated stents. The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF). The investigational follow-up will be at 30 days, 4 and 9 months.Effectiveness of the therapies on neomyogenesis will be measured by Magnetic Resonance Imaging analysis of left ventricular size and global and regional function and the myocardial viability.The impact of the therapies on stent re-endothelialization and restenosis will be analysed by angiography and intracoronary ultrasounds at 30 days and 9 months. The impact of the different treatments on neoangiogenesis will be measured by infarct related artery intracoronary study of the evolution of coronary flow reserve. Also, it will be measured the haematopoietic precursors kinetic in the different treatment branches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
G-CSF will be administered at a dose of 10 mcg/kg/day. The administration begins at the first 24 hours post-reperfusion, remaining for 5 days
Bone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration
Hospital Universitario de Valladolid
Valladolid, Valladolid, Spain
RECRUITINGThe change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance
Time frame: 9 months
The change in left ventricle end-dyastolyc volume, segment contractility, wall thickness and intravascular ultrasound reendothelization relative to baseline measured by magnetic resonance and other imaging techniques
Time frame: 9 months
To determine the safety of the study procedures
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.