REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Single Dose Efficacy	Epoetin alfa	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.
Dose Escalation Safety	Epoetin alfa	The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.

Primary Outcome Measures

Name	Time	Method
Infarct Size in the Territory of the Infarct Related Artery	performed 2 to 6 days after study medication administration (first CMR)	Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.

Secondary Outcome Measures

Name	Time	Method
Infarct Size in the Territory of the Infarct Related Artery	12 ± 2 weeks after study medication	Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
LV Ejection Fraction	2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
LV Volume Indexed to BSA	2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
LV Mass Indexed to BSA	2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
Vital Signs	baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Hemoglobin Levels	baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Reticulocyte Counts	baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Number of Participants With Clinical Events	from randomization to second CMR

Locations (16): Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Cornell University
🇺🇸
New York, New York, United States
Duke University
🇺🇸
Durham, North Carolina, United States
Henry Ford Hospital
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Detroit, Michigan, United States
New York Methodist Hospital
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Brooklyn, New York, United States
Nashville Cardiovascular Magnetic Resonance Institute
🇺🇸
Brentwood, Tennessee, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Washington Hospital Center
🇺🇸
Washington, D.C., District of Columbia, United States
University of Miami, School of Medicine
🇺🇸
Miami, Florida, United States
Mayo Clinic, Rochester
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Rochester, Minnesota, United States
Virginia Commonwealth University Medical Center
🇺🇸
Richmond, Virginia, United States
Penn State Heart and Vascular Institute
🇺🇸
Hershey, Pennsylvania, United States
Weill Medical College
🇺🇸
New York, New York, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
NY Presbyterian Hospital
🇺🇸
New York, New York, United States
Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States