Acute ST Elevation Myocardial InfarctionPhase 2NCT00378352
REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
A Phase 2 study testing Epoetin alfa in people with Acute ST Elevation Myocardial Infarction, run by National Institute on Aging (NIA) at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute ST Elevation Myocardial Infarction
- What is being tested?
- Epoetin alfa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 16 sitesUnited States
- Study dates
- Sep 2005to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University Hospital
Atlanta, Georgia, 30322
Nashville Cardiovascular Magnetic Resonance Institute
Brentwood, Tennessee, 37027
New York Methodist Hospital
Brooklyn, New York, 11215
Ohio State University Medical Center
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Penn State Heart and Vascular Institute
Hershey, Pennsylvania, 17033
University of Miami, School of Medicine
Miami, Florida, 33136
Cornell University
New York, New York, 10021-4872
NY Presbyterian Hospital
New York, New York, 10021
Weill Medical College
New York, New York, 10021
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073-6769
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute ST Elevation Myocardial Infarction
- Being tested
- Epoetin alfa
- Keywords
- Acute Myocardial Infarction, Left Ventricular Remodeling, Cardiac Magnetic Resonance Imaging, Endothelial Progenitor Cells, Infarct Size
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alfaDrug
Also called PROCRIT
Randomized
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Safety | Placebo comparator | The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs. Receives: Drug: Epoetin alfa |
| Single Dose Efficacy | Placebo comparator | 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. Receives: Drug: Epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: performed 2 to 6 days after study medication administration (first CMR)
Secondary outcomes (8)
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.
Measured: 12 ± 2 weeks after study medication
LV Ejection Fraction
Measured: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
LV Volume Indexed to BSA
Measured: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
LV Mass Indexed to BSA
Measured: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
Vital Signs
Measured: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Hemoglobin Levels
Measured: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Reticulocyte Counts
Measured: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
Number of Participants With Clinical Events
Measured: from randomization to second CMR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startSep 2005
- Primary completionJul 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Edward G Lakatta, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378352
- Sponsor's protocol ID
- 999905255
- Other IDs
- 05-AG-N255
- Status last verified
- May 2017
- First submitted
- 18 Sep 2006
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15249178Parsa 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.
PubMed 14523037Maiese 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.
PubMed 15632341Povsic 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.
PubMed 23700090Najjar 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.
PubMed 21558517Melloni 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.
PubMed 21095264
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions
- ClinicalTrials.gov ID
- NCT00378352
- Acronym / sponsor ID
- 999905255
- Conditions
- Acute ST Elevation Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Left Ventricular Remodeling, Cardiac Magnetic Resonance Imaging, Endothelial Progenitor Cells, Infarct Size
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Sep 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Sep 2006 (estimated)
- Results
- Posted 9 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Safety | Placebo comparator | Drug: Epoetin alfaThe objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs. |
| Single Dose Efficacy | Placebo comparator | Drug: Epoetin alfaSingle 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin alfaAlso: PROCRITRandomized | Drug | Dose Escalation Safety, Single Dose Efficacy |
Primary outcome
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.
8 secondary outcomes
Infarct Size in the Territory of the Infarct Related Artery
Time frame: 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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15249178Bogoyevitch 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.
- Background: PubMed 14523037Parsa 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.
- Background: PubMed 15632341Maiese 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.
- Background: PubMed 23700090Povsic 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 publication: PubMed 21558517Najjar 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.
- Derived from this study: PubMed 21095264Melloni 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.
- Individual participant dataSharing planned: No
Related trials for Acute ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Not yet recruitingPhase 4
IMPROVE-STEMI: pPCI Plus Low-dose r-SK in STEMI
ST Elevation Myocardial Infarction (STEMI)
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward G Lakatta, M.D. principal investigator
National Institute on Aging (NIA)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epoetin alfa in people with Acute ST Elevation Myocardial Infarction, run by National Institute on Aging (NIA) at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Size in the Territory of the Infarct Related Artery (time frame: performed 2 to 6 days after study medication administration (first CMR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378352, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.