Acute Myocardial Infarction Clinical Trial
Official title:
Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction.
The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)
This study protocol describes a randomized double blind clinical trial, which main purpose
is to evaluate the effect of the autologous bone marrow mononuclear cell (ABMMC) implant in
300 Brazilian patients with ST elevation acute myocardial infarction (STEMI).
Double blind study design was chosen for this trial, based on several phase I and II safety
trials of intracoronary autologous bone marrow stem cells transplantation, already
published. The study coordinator committee, supported by the Brazilian Health Ministry,
therefore has proposed a phase III trial with the purpose of proving the efficacy of this
kind of therapy, for a population with a high risk of developing heart failure and of death
by cardiovascular cause.
Thus, in this protocol we propose a prospective, double blind, controlled and randomized
trial to evaluate the effect of ABMMC transplantation through intracoronary infusion, on
systolic left ventricle (LV) function. The main hypothesis of this trial is that patients
submitted to autologous bone marrow stem cell implant, after 6 months follow up, will
present a 5% relative increase of the ejection fraction (EF) comparing to control group.
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