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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00378352
First received: September 18, 2006
Last updated: May 8, 2017
Last verified: May 2017
  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: Epoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Infarct Size in the Territory of the Infarct Related Artery [ Time Frame: 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:
  • Infarct Size in the Territory of the Infarct Related Artery [ Time Frame: 12 ± 2 weeks after study medication ]
    Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.

  • 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 ]

Enrollment: 223
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
Placebo Comparator: Dose Escalation Safety
The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.
Drug: Epoetin alfa
Randomized
Other Name: PROCRIT
Placebo Comparator: Single Dose Efficacy
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.
Drug: Epoetin alfa
Randomized
Other Name: PROCRIT

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, District of Columbia
Washington Hospital Center
Washington, D.C., 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
NY Presbyterian Hospital
New York, New York, United States, 10021
Weill Medical College
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
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Edward G Lakatta, M.D. National Institute on Aging (NIA)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00378352     History of Changes
Other Study ID Numbers: 999905255
05-AG-N255 ( Other Identifier: NIH )
Study First Received: September 18, 2006
Results First Received: September 30, 2013
Last Updated: May 8, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on May 25, 2017