what is g-csf?

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

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

Two important G-CSF usesMOST COMMON: Post chemotherapy febrile neutropenia

Potent inducer of hematopoietic stem cell mobilization for stem cell transplantation

Side effects associated with G-CSF

STEMAMI Outcome trial: rationale

STEM AMI Outcome trial: rationale

STEMAMI Outcome trial: rationale

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


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.


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


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.


EXCLUSION CRITERIA

Previous anterior MI Recent MI (within 1 month) Known previous LV dysfunction (EF


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


ASSESMENT II DAY 0-7In Hospital phase G-CSF administrationHemochrome (WBC count)Documentation of ADRs/SAEsECGECHO: EF (Echo Simpson biplane), EDV and ESV


ASSESMENT III DAY 301-month visit

Clinical EvaluationDocumentation of ADRs/SAEsECG


ASSESMENT IV DAY 1806-months visit

Clinical EvaluationDocumentation of ADRs/SAEsECGECHO: EF (Echo Simpson biplane), EDV and ESV


ASSESMENT V DAY 36512-months visit

Phone interviewDocumentation of ADRs/SAEs


ASSESMENT V DAY 73024-months visitClinical EvaluationDocumentation of ADRs/SAEsECGECHO: EF (Echo Simpson biplane), EDV and ESV


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

what is g-csf?

Documents