The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
223
Randomized
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Miami, School of Medicine
Miami, Florida, United States
Infarct Size in the Territory of the Infarct Related Artery
Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
Time frame: performed 2 to 6 days after study medication administration (first CMR)
Infarct Size in the Territory of the Infarct Related Artery
Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
Time frame: 12 ± 2 weeks after study medication
LV Ejection Fraction
Time frame: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
LV Volume Indexed to BSA
Time frame: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
LV Mass Indexed to BSA
Time frame: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
Vital Signs
Time frame: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Hemoglobin Levels
Time frame: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Reticulocyte Counts
Time frame: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Number of Participants With Clinical Events
Time frame: from randomization to second CMR
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