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

May 8, 2017 updated by: National Institute on Aging (NIA)

Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions

The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Royal Oak, Michigan, United States, 48073-6769
        • William Beaumont Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Rochester
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
      • New York, New York, United States, 10021-4872
        • Cornell University
      • New York, New York, United States, 10021
        • NY Presbyterian Hospital
      • New York, New York, United States, 10021
        • Weill Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Heart and Vascular Institute
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Nashville Cardiovascular Magnetic Resonance Institute
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • PROCRIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
performed 2 to 6 days after study medication administration (first CMR)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 ± 2 weeks after study medication
LV Ejection Fraction
Time Frame: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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)
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)
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
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
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
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
from randomization to second CMR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Edward G Lakatta, M.D., National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (Estimate)

September 20, 2006

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999905255
  • 05-AG-N255 (Other Identifier: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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