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NCT01969890 Clinical Trial

STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial

Left Ventricular Systolic Dysfunction Clinical Trial

— STEM-AMI  

Official title:
Phase III Study on STem cElls Mobilization in Acute Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01969890
Other study ID # G112
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 2013
Est. completion date May 2018

Study information
Verified date August 2018
Source Heart Care Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that granulocyte colony-stimulating factor (G-CSF) therapy in addition to state-of-the-art treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patients with reduced left ventricular ejection fraction (LVEF) (≤45%) after successful reperfusion for large anterior acute myocardial infarction.

Description:

Post infarction heart failure (HF) remains a major cause of morbidity and mortality. In the United States, more than three million patients, and 700.000 in Italy, have cardiac failure and its most common cause is ischemic heart disease. The major goal to improve post infarction LV function would be the stimulation of neovascularization and the enhancement of regeneration of cardiac myocytes within the infarcted area. Recent experimental studies suggest that bone marrow-derived progenitor cells (BMCs) or circulating endothelial progenitor cells (cEPCs) contribute to the regeneration of infarcted myocardium, to enhance neovascularization of ischemic myocardium, to prevent cardiomyocyte apoptosis, to alter scar formation by reducing the development of myocardial fibrosis and, thereby, to improve cardiac function. G-CSF is a hematopoietic cytokine produced by monocytes, fibroblasts and endothelial cells. G-CSF is known to have multiple functions in normal, steady-state hematopoiesis. It is routinely used to mobilize CD34+ hematopoietic stem cells from the BM into peripheral blood, thus enabling their easier collection compared to BM aspirate procedure. The proven efficacy and safety of G-CSF, both in healthy donors and patients with haematological disease, along with favourable results from studies of CD34+ cell transplantation in patients with MI or ischemia, suggest that G-CSF based BMC transplantation may have an efficacy in patients with MI.

Recruitment information / eligibility
Status Terminated
Enrollment 532
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients affected by acute anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) or PCI-rescue with persistent occlusion of coronary artery, - Time symptom-to-balloon (=3 h and =12h or =24 h if symptoms persist), - Thrombolysis in Myocardial Infarction (TIMI) flow post PCI =2, - Evidence of left ventricular (LV) dysfunction (EF biplane =45%) =24 h after revascularization, - Men 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 <45%), - Patients with angiographic evidence of coronary anatomy not suitable for PCI, or needing coronary artery bypass grafting (CABG), - Valve disease requiring surgical correction, - History of previous cardiac surgery or PCI on LAD within 6 months, - Previous or current documented history of leukemia, myeloproliferative or myelodysplastic disorder, - Previous or current documented history of malignant disease, - Haemoglobin <10 mg/dl, - White blood cells (WBC) >25.000 mm3, - Platelet <50.000 mm3, - Sepsis, - Known HIV infection, - Immune system diseases, - Interstitial lung disease - Serious concomitant medical conditions (other than ischemic heart disease), - Pregnancy and breast feeding, - Documented alcohol and drug abuse, - Anticipated poor compliance. - Current participation in a clinical trial with other investigational products - Other cell therapy.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• G-CSF administration
Zarzio - 5 microg/kg bis in die for 6 days

Locations
Country Name City State
Italy Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC Ancona AN
Italy Ospedale San Donato - UO Cardiologia Arezzo AR
Italy Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia Ascoli Piceno AP
Italy AORN Giuseppe Moscati - UO Cardiologia-UTIC Avellino AV
Italy Humanitas Gavazzeni - UO Cardiologia Bergamo BG
Italy Ospedale Maggiore - UO Cardiologia Bologna BO
Italy Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia Busto Arsizio VA
Italy Ospedale Sant'Elia - Cardiologia-UTIC Caltanissetta CL
Italy Ospedale Bassini - UO Cardiologia e UTIC Cinisello Balsamo MI
Italy Ospedale Maggiore - UO Cardiologia e UTIC Crema CR
Italy Istituti Ospitalieri - UO Cardiologia Cremona CR
Italy Ospedale di Circolo - UOC Cardiologia - UTIC Desio MB
Italy AOU Careggi - Cardiologia Generale 1 Firenze FI
Italy IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia Genova GE
Italy Ospedale Moriggia Pelascini - UO Cardiologia Gravedona CO
Italy Ospedale della Misericordia - UO Cardiologia Grosseto GR
Italy Ospedale Alessandro Manzoni - SCD Cardiologia Lecco LC
Italy Ospedale Civile - UTIC - Cardiologia Legnano MI
Italy Ospedale Campo Marte - UO Cardiologia Lucca LU
Italy Presidio Ospedaliero Carlo Poma - UO Cardiologia Mantova MN
Italy Ospedale dell'Angelo - UO Cardiologia Mestre VE
Italy Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC Milano MI
Italy Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC Milano MI
Italy Ospedale L. Sacco - Divisione di Cardiologia Milano MI
Italy Ospedale Maggiore Policlinico - Divisione di Cardiologia Milano MI
Italy Ospedale Niguarda - Cardiologia 1 - Emodinamica Milano MI
Italy Ospedale San Carlo Borromeo - Cardiologia UCC Milano MI
Italy Ospedale San Luca - Centro Auxologico - UO Cardiologia Milano MI
Italy Ospedale San Paolo - Divisione di Cardiologia Milano MI
Italy Ospedale San Gerardo - UO Cardiologia UTIC Monza MB
Italy AORN Cardarelli - UO SC Cardiologia con UTIC Napoli
Italy AOU Federico II - UTIC Napoli
Italy AO Univ. Maggiore della Carità - Cardiologia 2 Novara
Italy Ospedale San Francesco - Cardiologia UTIC Nuoro NU
Italy Ospedale Giovanni Paolo II - UTIC Cardiologia Olbia OT
Italy Azienda Ospedaliera Padova - Clinica Cardiologica Padova PD
Italy Fondazione IRCCS Policlinico San Matteo - Card. con UCC-Lab. Ricerca Sperim. Card. Pavia PV
Italy Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia Piacenza PC
Italy AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello Pisa PI
Italy Arcispedale Santa Maria Nuova - UO Degenza Cardiologica Reggio Emilia RE
Italy Ospedale Infermi - UO Cardiologia Rimini RN
Italy AO San Giovanni Addolorata - Cardiologia 2 Roma RM
Italy Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC Rozzano MI
Italy AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC Salerno SA
Italy Ospedale Sant'Anna - UOC Cardiologia San Fermo della Battaglia CO
Italy Presidio Ospedaliero - UO Cardiologia Sanremo IM
Italy Presidio Ospedaliero di Saronno - UOC Cardiologia Saronno VA
Italy Ospedale Bolognini - Divisione di Cardiologia Seriate BG
Italy AOU San Giovanni Battista - SCDU Cardiologia 1 Torino TO
Italy Ospedale Ca' Foncello - UOC Cardiologia Treviso TV
Italy AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara Trieste TS
Italy Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche Varese VA
Italy Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica Viterbo VT

Sponsors (3)
Lead Sponsor Collaborator
Heart Care Foundation A. Manzoni Hospital, Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Achilli F, Malafronte C, Cesana F, Maggiolini S, Mauro C, De Ferrari GM, Lenatti L, Tespili M, Pasqualini P, Gentile F, Capogrossi MC, Maggioni A, Maseri A, Pontone G, Colombo GI, Pompilio G; STEM-AMI OUTCOME Trial Investigators. Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction: rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial. Am Heart J. 2015 Oct;170(4):652-658.e7. doi: 10.1016/j.ahj.2015.07.005. Epub 2015 Jul 12. — View Citation

Achilli F, Pontone G, Bassetti B, Squadroni L, Campodonico J, Corrada E, Facchini C, Mircoli L, Esposito G, Scarpa D, Pidello S, Righetti S, Di Gennaro F, Guglielmo M, Muscogiuri G, Baggiano A, Limido A, Lenatti L, Di Tano G, Malafronte C, Soffici F, Ceseri M, Maggiolini S, Colombo GI, Pompilio G; STEM-AMI OUTCOME CMR Sub-Study Investigators. G-CSF for Extensive STEMI. Circ Res. 2019 Jul 19;125(3):295-306. doi: 10.1161/CIRCRESAHA.118.314617. Epub 2019 May 29. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Safety endpoints - Incidence and severity of bleeding complications, - incidence of malignancy, - incidence and intensity of serious adverse events (SAEs) and adverse drug reactions (ADRs) two years
Primary The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure. two years
Secondary - All cause death and cardiovascular events The following Cardiovascular events will be assessed:
recurrence of MI,
hospitalization due to heart failure,
cardiovascular death,
coronary revascularization,
fatal and non fatal stroke,
hospitalization due to any cause,
cardiovascular hospitalization,
resuscitation and/or appropriate automated implanted cardioverter defibrillator(AICD) therapy.		 two years
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