REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
8. mai 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
223
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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District of Columbia
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Washington, D.C., District of Columbia, Forente stater, 20010
- Washington Hospital Center
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Florida
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Miami, Florida, Forente stater, 33136
- University of Miami, School of Medicine
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Royal Oak, Michigan, Forente stater, 48073-6769
- William Beaumont Hospital
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic, Rochester
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New York
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Brooklyn, New York, Forente stater, 11215
- New York Methodist Hospital
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New York, New York, Forente stater, 10021-4872
- Cornell University
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New York, New York, Forente stater, 10021
- NY Presbyterian Hospital
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New York, New York, Forente stater, 10021
- Weill Medical College
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University
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Winston-Salem, North Carolina, Forente stater, 27103
- Wake Forest University
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Ohio
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Columbus, Ohio, Forente stater, 43210
- Ohio State University Medical Center
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Pennsylvania
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Hershey, Pennsylvania, Forente stater, 17033
- Penn State Heart and Vascular Institute
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Tennessee
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Brentwood, Tennessee, Forente stater, 37027
- Nashville Cardiovascular Magnetic Resonance Institute
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Virginia
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Richmond, Virginia, Forente stater, 23298
- Virginia Commonwealth University Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Dose Escalation Safety
The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.
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Randomized
Andre navn:
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Placebo komparator: 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.
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Randomized
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Infarct Size in the Territory of the Infarct Related Artery
Tidsramme: performed 2 to 6 days after study medication administration (first CMR)
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Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
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performed 2 to 6 days after study medication administration (first CMR)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Infarct Size in the Territory of the Infarct Related Artery
Tidsramme: 12 ± 2 weeks after study medication
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Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
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12 ± 2 weeks after study medication
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LV Ejection Fraction
Tidsramme: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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LV Volume Indexed to BSA
Tidsramme: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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LV Mass Indexed to BSA
Tidsramme: 2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)
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Vital Signs
Tidsramme: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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Hemoglobin Levels
Tidsramme: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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Reticulocyte Counts
Tidsramme: baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days
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Number of Participants With Clinical Events
Tidsramme: from randomization to second CMR
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from randomization to second CMR
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Edward G Lakatta, M.D., National Institute on Aging (NIA)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2005
Primær fullføring (Faktiske)
1. juli 2009
Studiet fullført (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først innsendt
18. september 2006
Først innsendt som oppfylte QC-kriteriene
18. september 2006
Først lagt ut (Anslag)
20. september 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 999905255
- 05-AG-N255 (Annen identifikator: NIH)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
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