REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00378352

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: Erythropoietin (Epoetin alfa) Drug: Placebo	Phase II

MedlinePlus related topics: Heart Attack

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

End-systolic volume, end-diastolic 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 ]
Changes 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:	210
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 15,000 Units	Drug: Erythropoietin (Epoetin alfa) Single parenteral administration
2: Experimental 30,000 Units	Drug: Erythropoietin (Epoetin alfa) Single parenteral administration
3: Experimental 60,000 Units	Drug: Erythropoietin (Epoetin alfa) Single parenteral administration
4: Placebo Comparator	Drug: Placebo single parenteral administration of saline placebo

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

Criteria

Inclusion Criteria:

Age > 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 > 42% in men or > 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378352

Contacts

Contact: Sunil V. Rao, MD

919-286-0411 ext 2352

rao00010@duke.edu

Locations

United States, District of Columbia
Washington Hospital Center	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ron Waksman, MD 202-877-5975 ron.waksman@medstar.net
Contact: Rekha Gavini 202-877-7066 Rekha.Gavini@medstar.net
United States, Florida
University of Miami, School of Medicine	Recruiting
Miami, Florida, United States, 33136
Contact: Eduardo de Marchena, MD 305-585-5535 emarchen@med.miami.edu
Contact: Christian Marin 305-585-6217 CMarin@med.miami.edu
United States, Georgia
Emory University Hospital	Recruiting
Atlanta, Georgia, United States, 30322
Contact: John S. Douglas Jr., MD 404-727-7040 john.douglas@emoryhealthcare.org
Contact: Mary Pennington, PA 404-712-7623 mary.pennington@emoryhealthcare.org
United States, Michigan
Henry Ford Hospital	Recruiting
Detroit, Michigan, United States, 48202
Contact: Adam B Greenbaum, MD 313-916-3875 agreenb1@hfhs.org
Contact: Julianne Longlade, RN, BSN 313-916-3498 jlongla1@hfhs.org
William Beaumont Hospital	Terminated
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic-St. Mary's Hospital	Recruiting
Rochester, Minnesota, United States, 55902
Contact: Gregory Barsness, MD 507-255-6092 barsness.gregory@mayo.edu
Contact: Lynn Polk 507-255-2527 polk.lynn@mayo.edu
United States, New York
Weill Medical College, Cornell University, NY Presbyterian Hospital	Terminated
New York, New York, United States, 10021
New York Methodist Hospital	Recruiting
Brooklyn, New York, United States, 11215
Contact: John Heitner, MD 718-780-5037 jfh9003@nyp.org
Contact: Mahmoud Hammad 718-780-5616 ehabhammad@gmail.com
United States, North Carolina
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Sanjay K. Gandhi, MD 336-716-2095 sgandhi@wfubmc.edu
Contact: Teresa Young, RTR 336-713-4432 tyoung@wfubmc.edu
Duke University Health System	Recruiting
Durham, North Carolina, United States, 27710
Contact: Sunil V. Rao, MD 919-286-0411 ext 2352 rao00010@dcri.duke.edu
Contact: Jennifer Hervey 919-681-3511 herve003@mc.duke.edu
United States, Ohio
Ohio State University Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Subha V. Raman, MD 614-293-8963 Raman.1@osu.edu
Contact: Beth McCarthy 614-293-3855 Beth.McCarthy@osumc.edu
United States, Pennsylvania
Penn State Heart & Vascular Institute	Terminated
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Nashville Cardiovascular Magnetic Resonance Institute	Terminated
Brentwood, Tennessee, United States, 37027
United States, Virginia
Virginia Commonwealth University Medical Center	Recruiting
Richmond, Virginia, United States, 23298
Contact: Michael C. Kontos, MD 804-828-9989 mckontos@vcu.edu
Contact: Lenore Roach, BSN 804-828-1601 lmroach@vcu.edu

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Study Chair:	Samer S. Najjar, MD	National Institute on Aging (NIA)
Principal Investigator:	Robert A. Harrington, MD,FACC,FSCAI	Duke University

More Information

Publications:

Maiese K, Li F, Chong ZZ. New avenues of exploration for erythropoietin. JAMA. 2005 Jan 5;293(1):90-5. Review.

Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. Review.

Parsa CJ, Matsumoto A, Kim J, Riel RU, Pascal LS, Walton GB, Thompson RB, Petrofski JA, Annex BH, Stamler JS, Koch WJ. A novel protective effect of erythropoietin in the infarcted heart. J Clin Invest. 2003 Oct;112(7):999-1007.

Moon C, Krawczyk M, Ahn D, Ahmet I, Paik D, Lakatta EG, Talan MI. Erythropoietin reduces myocardial infarction and left ventricular functional decline after coronary artery ligation in rats. Proc Natl Acad Sci U S A. 2003 Sep 30;100(20):11612-7. Epub 2003 Sep 19.

Moon C, Krawczyk M, Paik D, Lakatta EG, Talan MI. Cardioprotection by recombinant human erythropoietin following acute experimental myocardial infarction: dose response and therapeutic window. Cardiovasc Drugs Ther. 2005 Aug;19(4):243-50.

Responsible Party:	National Institute on Aging ( Samer Najjar, MD )
Study ID Numbers:	AG0068, AG-260-05-10
Study First Received:	September 18, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00378352 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epoetin Alfa
Necrosis
Heart Diseases
Hematinics
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Epoetin Alfa
Heart Diseases
Hematinics
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Ischemia

Pharmacologic Actions
Necrosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009