What is G-CSF?
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Transcript of What is G-CSF?
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STEM-AMI OUTCOME TRIAL
STem cElls Mobilization in Acute Myocardial Infarction Outcome TrialA national, multicentre, randomised, open-label, Phase III study
Dott. Luca DeferrariU.O. CardiologiaIRCCS San Martino, Genova
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What is G-CSF?Granulocyte Colony Stimulating FactorGlycoproteinGrowth factorCytokine
Produced by endothelium, macrophages and other immune cells
G-CSF receptor present on precursor cells in the bone marrowInitiates proliferation and differentiation into mature granulocytesStimulates bone marrow cell release into circulation
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Two important G-CSF usesMOST COMMON: Post chemotherapy febrile neutropenia
Potent inducer of hematopoietic stem cell mobilization for stem cell transplantation
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Side effects associated with G-CSF
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STEMAMI Outcome trial: rationale
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STEMAMI Outcome trial: rationale
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STEMAMI Outcome trial: rationale
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STEM AMI Outcome trial: rationale
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STEMAMI Outcome trial: rationale
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STEMAMI Outcome trial: rationale
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STEMAMI Outcome trial: rationale
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STUDY OBJECTIVES
To demonstrate that G-CSF in addition to state of the art treatment is safe and significantly improves clinical outcome in patients with reduced left ventricular EF (45%) after successful reperfusion for large anterior acute myocardial infarction STEM-AMI OUTCOME TRIAL
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STEM-AMI OUTCOME TRIAL
DESIGN Phase III, randomized, open label. 1530 Patients (50 centres) will be randomized to standard therapy + G-CSF or standard therapy alone in 1:1 ratio.Accrual time 3 years. Follow-up time 2 years.
TREATMENTFILGRASTIM 5 g/kg will be administered subcutaneously bis in die for 6 days (from Day 1 to Day 6), starting within 24 h after PCI and reperfusion.
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STEM-AMI OUTCOME TRIAL
PRIMARY EFFICACY END POINT
Clinical outcome will be assessed by the composite endpoint of:death orrecurrence of MI orhospitalization due to heart failure
SAFETY ENDPOINTS
Incidence and severity of bleeding complicationsIncidence of malignancyIncidence and intensity of AEs and SAEs
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STEM-AMI OUTCOME TRIAL
INCLUSION CRITERIA
Patients affected by acute anterior STEMI undergoing primary PCI (or PCI-rescue with persistent occlusion of coronary artery) Time symptom-to-balloon 3 h and 12h (or 24 h if symptoms persist) TIMI flow post PCI 2 Evidence of LV dysfunction (EF biplane 45%) 24 h after revascularizationMen and women aged 18 years and 75 years, Informed consent must be signed before proceeding with any study procedure.
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STEM-AMI OUTCOME TRIAL
EXCLUSION CRITERIA
Previous anterior MI Recent MI (within 1 month) Known previous LV dysfunction (EF
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STEM-AMI OUTCOME TRIAL
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STEM-AMI OUTCOME TRIAL
ASSESMENT I DAY -1/0Screening and randomization Obtain written informed consent Documented acute anterior STEMI Documented primary PCI/PCI-rescue (symptom to ballon time) TIMI flow post-PCI registration Evidence of Echo Simpson biplane EF 45%, EDV and ESV Hemochrome (hemoglobin, platelets, WBC) Pregnancy test (if necessary) Determine patients eligibility for enrollment Randomization to study treatment group
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STEM-AMI OUTCOME TRIAL
ASSESMENT II DAY 0-7In Hospital phase G-CSF administrationHemochrome (WBC count)Documentation of ADRs/SAEsECGECHO: EF (Echo Simpson biplane), EDV and ESV
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STEM-AMI OUTCOME TRIAL
ASSESMENT III DAY 301-month visit
Clinical EvaluationDocumentation of ADRs/SAEsECG
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STEM-AMI OUTCOME TRIAL
ASSESMENT IV DAY 1806-months visit
Clinical EvaluationDocumentation of ADRs/SAEsECGECHO: EF (Echo Simpson biplane), EDV and ESV
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STEM-AMI OUTCOME TRIAL
ASSESMENT V DAY 36512-months visit
Phone interviewDocumentation of ADRs/SAEs
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STEM-AMI OUTCOME TRIAL
ASSESMENT V DAY 73024-months visitClinical EvaluationDocumentation of ADRs/SAEsECGECHO: EF (Echo Simpson biplane), EDV and ESV
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STEM-AMI OUTCOME TRIAL
Egregi Dottori, Con la presente, comunichiamo che oggi, 8 novembre 2013, stato arruolato il primo paziente dello Studio STEM-AMI Outcome dall'Ospedale San Gerardo di Monza. Cordialmente Segreteria Organizzativa Centro di Coordinamento Centro Studi ANMCO Grazie per lattenzione