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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
166
Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.
PROCEP/Hospital Pró-Cardíaco
Rio de Janeiro, Rio de Janeiro, Brazil
Global Left Ventricular Ejection Fraction change
Time frame: 6 months
Death
Time frame: 30 days, 90 days, 6 months and 1 year
Acute myocardial infarction, stroke and hospital admission due to cardiovascular cause
Time frame: 30 days, 90 days, 6 months and 1 year
Reintervention of the AMI related artery and of the non-related artery
Time frame: 30 days, 90 days, 6 months and 1 year
Regional wall motion, wall thickening, and volume of late contrast enhancement
Time frame: Baseline and 6 months
Evolutive alterations of the coronarian anatomy, as well as the patency of the coronary stents
Time frame: 6 months
Quality of life assessment using the Short-Form 36, Minnesota Living with Heart Failure Questionnaire and Seattle Angina questionnaire
Time frame: Baseline, 6 months and 1 year
Cost-effectiveness and cost-utility evaluation of autologous bone marrow mononuclear cells implant versus conventional treatment
Time frame: 1 year
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