REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
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Purpose
The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute ST Elevation Myocardial Infarction |
Drug: Epoietin Alfa Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions |
- Changes in infarct size, as assessed by magnetic resonance imaging [ Time Frame: within 2-6 days of administration of study medication ] [ Designated as safety issue: No ]
- End-systolic volume, ejection fraction [ Time Frame: Within 2-6 days of administration of study medication, and 3 months later ] [ Designated as safety issue: No ]
- Number of circulating endothelial progenitor cells [ Time Frame: Within 2-6 days of administration of study medication, and 3 months later ] [ Designated as safety issue: No ]
- Changes in infarct size [ Time Frame: 3 months after administration of study medication ] [ Designated as safety issue: No ]
- Change in hemoglobin levels [ Time Frame: During the first two weeks following study medication administration ] [ Designated as safety issue: Yes ]
- Occurrence of death or arterial or venous thrombotic events [ Time Frame: Within 4 weeks following administration of study medication ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 250 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 15,000 Units
Single parenteral administration
|
Drug: Epoietin Alfa
N/A
|
|
Experimental: 30,000 Units
Single parenteral administration
|
Drug: Epoietin Alfa
N/A
|
|
Experimental: 60,000 Units
Single parenteral administration
|
Drug: Epoietin Alfa
N/A
|
|
Placebo Comparator: Placebo
Single parenteral administration of saline placebo
|
Drug: Placebo
N/A
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Age greater than 21 years
Acute ST-elevation myocardial infarction
Referral for primary or rescue angioplasty
Revascularization procedure within 8 hours from the onset of ischemic symptoms
TIMI (Thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary artery at the beginning of coronary angiography
Successful revascularization of infarct-related artery
EXCLUSION CRITERIA:
Clinical indication for erythropoietin
STEMI (ST-elevation myocardial infarction) due to occlusion of a branch vessel
Any history of prior MI, PCI (Percutaneous coronary intervention), CABG (Coronary artery bypass graft), cardiomyopathy, myocarditis, or CHF (congestive heart failure)
Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin
Hematocrit greater than 42% in men or greater than 40% in women at the time of study drug administration
Uncontrolled hypertension at the time of study drug administration
Cardiogenic shock
Need for coronary surgical revascularization as determined at the time of the index coronary catheterization
History of hypercoagulable disorder, thromboembolic event, or venous thrombosis
History of stroke or TIA (transient ischemic attack)
History of seizures
Contraindication to MRI
Pregnancy or nursing mother
Contacts and Locations| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| University of Miami, School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| United States, Minnesota | |
| Mayo Clinic, Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| New York Methodist Hospital | |
| Brooklyn, New York, United States, 11215 | |
| Cornell University | |
| New York, New York, United States, 10021-4872 | |
| Weill Medical College | |
| New York, New York, United States, 10021 | |
| NY Presbyterian Hospital | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Penn State Heart and Vascular Institute | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Tennessee | |
| Nashville Cardiovascular Magnetic Resonance Institute | |
| Brentwood, Tennessee, United States, 37027 | |
| United States, Virginia | |
| Virginia Commonwealth University Medical Center | |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: | Edward G Lakatta, M.D. | National Institute on Aging (NIA) |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Edward G. Lakatta, M.D./National Institute on Aging, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00378352 History of Changes |
| Other Study ID Numbers: | 999905255, 05-AG-N255 |
| Study First Received: | September 18, 2006 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Acute Myocardial Infarction Left Ventricular Remodeling Cardiac Magnetic Resonance Imaging Endothelial Progenitor Cells Infarct Size |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ventricular Remodeling Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Pathological Conditions, Anatomical Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013