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

Primary Purpose

Acute ST Elevation Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epoetin alfa
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST Elevation Myocardial Infarction focused on measuring Acute Myocardial Infarction, Left Ventricular Remodeling, Cardiac Magnetic Resonance Imaging, Endothelial Progenitor Cells, Infarct Size

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Washington Hospital Center
  • University of Miami, School of Medicine
  • Emory University Hospital
  • Henry Ford Hospital
  • William Beaumont Hospital
  • Mayo Clinic, Rochester
  • New York Methodist Hospital
  • Cornell University
  • NY Presbyterian Hospital
  • Weill Medical College
  • Duke University
  • Wake Forest University
  • Ohio State University Medical Center
  • Penn State Heart and Vascular Institute
  • Nashville Cardiovascular Magnetic Resonance Institute
  • Virginia Commonwealth University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

Dose Escalation Safety

Single Dose Efficacy

Arm Description

The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.

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.

Outcomes

Primary Outcome Measures

Infarct Size in the Territory of the Infarct Related Artery
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
Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
LV Ejection Fraction
LV Volume Indexed to BSA
LV Mass Indexed to BSA
Vital Signs
Hemoglobin Levels
Reticulocyte Counts
Number of Participants With Clinical Events

Full Information

First Posted
September 18, 2006
Last Updated
May 8, 2017
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00378352
Brief Title
REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
Official Title
Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Elevation Myocardial Infarction
Keywords
Acute Myocardial Infarction, Left Ventricular Remodeling, Cardiac Magnetic Resonance Imaging, Endothelial Progenitor Cells, Infarct Size

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Safety
Arm Type
Placebo Comparator
Arm Description
The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.
Arm Title
Single Dose Efficacy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Other Intervention Name(s)
PROCRIT
Intervention Description
Randomized
Primary Outcome Measure Information:
Title
Infarct Size in the Territory of the Infarct Related Artery
Description
Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
Time Frame
performed 2 to 6 days after study medication administration (first CMR)
Secondary Outcome Measure Information:
Title
Infarct Size in the Territory of the Infarct Related Artery
Description
Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
Time Frame
12 ± 2 weeks after study medication
Title
LV Ejection Fraction
Time Frame
2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
Title
LV Volume Indexed to BSA
Time Frame
2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
Title
LV Mass Indexed to BSA
Time Frame
2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
Title
Vital Signs
Time Frame
baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Title
Hemoglobin Levels
Time Frame
baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Title
Reticulocyte Counts
Time Frame
baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Title
Number of Participants With Clinical Events
Time Frame
from randomization to second CMR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward G Lakatta, M.D.
Organizational Affiliation
National Institute on Aging (NIA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami, School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021-4872
Country
United States
Facility Name
NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Heart and Vascular Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Nashville Cardiovascular Magnetic Resonance Institute
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15249178
Citation
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. doi: 10.1016/j.cardiores.2004.03.017.
Results Reference
background
PubMed Identifier
14523037
Citation
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. doi: 10.1172/JCI18200.
Results Reference
background
PubMed Identifier
15632341
Citation
Maiese K, Li F, Chong ZZ. New avenues of exploration for erythropoietin. JAMA. 2005 Jan 5;293(1):90-5. doi: 10.1001/jama.293.1.90.
Results Reference
background
PubMed Identifier
23700090
Citation
Povsic TJ, Najjar SS, Prather K, Zhou J, Adams SD, Zavodni KL, Kelly F, Melton LG, Hasselblad V, Heitner JF, Raman SV, Barsness GW, Patel MR, Kim RJ, Lakatta EG, Harrington RA, Rao SV. EPC mobilization after erythropoietin treatment in acute ST-elevation myocardial infarction: the REVEAL EPC substudy. J Thromb Thrombolysis. 2013 Nov;36(4):375-83. doi: 10.1007/s11239-013-0944-6.
Results Reference
background
PubMed Identifier
21558517
Citation
Najjar SS, Rao SV, Melloni C, Raman SV, Povsic TJ, Melton L, Barsness GW, Prather K, Heitner JF, Kilaru R, Gruberg L, Hasselblad V, Greenbaum AB, Patel M, Kim RJ, Talan M, Ferrucci L, Longo DL, Lakatta EG, Harrington RA; REVEAL Investigators. Intravenous erythropoietin in patients with ST-segment elevation myocardial infarction: REVEAL: a randomized controlled trial. JAMA. 2011 May 11;305(18):1863-72. doi: 10.1001/jama.2011.592.
Results Reference
result
PubMed Identifier
21095264
Citation
Melloni C, Rao SV, Povsic TJ, Melton L, Kim RJ, Kilaru R, Patel MR, Talan M, Ferrucci L, Longo DL, Lakatta EG, Najjar SS, Harrington RA. Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial. Am Heart J. 2010 Nov;160(5):795-803.e2. doi: 10.1016/j.ahj.2010.09.007.
Results Reference
derived

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

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