Conditions: Acute ST Elevation Myocardial Infarction
Keywords: Acute Myocardial Infarction Left Ventricular Remodeling Cardiac Magnetic Resonance Imaging Endothelial Progenitor Cells Infarct Size
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 223
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.

Detailed description:
REVEAL is a randomized, double-blinded, placebo-controlled, parallel phase II clinical study that will evaluate the effects of erythropoietin administration on infarct size, left ventricular remodeling and circulating endothelial progenitor cells in patients with large myocardial infarctions (MI). The study will be conducted in two phases: a dose-escalation safety phase and a single dose efficacy phase. Eligible patients who present to the hospital with an acute ST-elevation MI and who agree to participate in this study will be randomly assigned to receive a single infusion of study medication consisting either of erythropoietin or placebo. The size of the infarction and the dimensions of the heart will be assessed by cardiac magnetic resonance imaging (MRI) within 2-6 days of the infusion of the study medication, and again approximately 3 months later.

Arms:
arm 1: The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs. arm 2: Single parenteral administration of 60000 U of epoetin alfa. The objectives of the second phase are to investigate the effects of the highest safe dose on infarct size, left ventricular remodeling and endothelial progenitor cells.

Interventions: intervention 1: Epoetin alfa
Intervention descriptions: intervention 1: Randomized

Protocol document: