REVEAL

Title: REVEAL – Randomized, Multi-Center, Double-blind, Placebo-Controlled, Trial of the Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions 

Study Sponsor: National Institutes on Aging (NIA) of the National Institutes of Health (NIH)

Principal Investigator: Jay H. Traverse, MD

Study Status: CLOSED TO ENROLLMENT

Study Synopsis: Erythropoietin (pronounced ĭ-rĭth'rō-poi-ē'tĭn) is a protein found naturally in your body, which regulates the number of red blood cells (the cells that carry oxygen) in your blood. Epoetin alfa (Procrit®) is the name of the man-made erythropoietin drug, and it has been approved by the FDA for the treatment of low red blood cell counts (anemia). Recent studies with animals have shown that erythropoietin reduces the area of muscle damage in the heart and reduces the heart enlargement that occurs after a heart attack. Therefore, in this study, we would like to evaluate whether Epoetin alfa has these same beneficial effects in people with heart attacks. 

If you qualify and agree to participate, you are given one dose of the study drug immediately after your heart attack emergency angioplasty. You will be followed for the rest of your hospital stay. You will be asked to return to the Minneapolis Heart Institute at Abbott Northwestern for 4 visits in the next 3 months. Your participation lasts 3 months.

How do I qualify? To participate in this study, you have just had your first heart attack. You must present to the hospital in less than 8 hours from the start of the chest pain. Your treatment of the heart includes the regular treatment that includes opening the heart artery that was responsible for your heart attack. Certain other criteria determine if you qualify for the study. If you do qualify, the research nurse will talk with you and your family immediately after your heart attack treatment. If you agree, the study drug (either Procrit or placebo) needs to be given to you within 4 hours of the emergency angioplasty.

Status: CLOSED

Whom do I contact for more information? Beth Jorgenson, RN or contact research at 612.863.3980

Inclusion Criteria

1. Age ≥ 21 years.
2. Acute STEMI (or new left bundle branch block) due to occlusion of a major epicardial coronary artery or a large branch vessel.
3. Referral for primary or rescue angioplasty.
4. Revascularization procedure within 8 hours from the onset of ischemic symptoms.
5. TIMI flow grade 0 or 1 in the culprit coronary artery at the beginning of coronary angiography.
6. Successful revascularization of infarct-related artery defined as:
   1. <50% residual lesion
   2. TIMI flow grade 2 or 3

Exclusion Criteria

1. Clinical indication for Epoetin alfa (PROCRIT^®).
2. Any history of LVEF < 50%, or prior MI, or prior CABG.
3. Prior PCI in the infarct related artery.
4. Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin.
5. Hematocrit above the upper limit of normal for the institution at the time of study drug administration.
6. Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) at the time of study drug administration.
7. Cardiogenic shock defined as:
   1. Hypotension (SBP < 100) despite the use of vasopressors, or
   2. Evidence of tissue hypoperfusion, such as cold extremities and diminished urine output despite the use of vasopressors and/or an intra-aortic balloon pump.
8. Need for coronary surgical revascularization as determined at the time of the index coronary catheterization.
9. History of hypercoagulable disorder, thromboembolic event, or venous thrombosis.
10. History of stroke or TIA.
11. History of seizures.
12. Contraindication to MRI (e.g. pacemaker, AICD, aneurysm clips, cochlear implants, retinal tacks, inability to lie flat for 45–60 min, inability to hold breath for 15 sec, or penile implants.)
13. Pregnant or nursing women.
14. Contraindication to Gadolinium contrast, such as glomerular filtration rate <30ml/min/1.73m²