STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial (STEM-AMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Heart Care Foundation
Sponsor:
Collaborators:
A. Manzoni Hospital
Centro Cardiologico Monzino
Information provided by (Responsible Party):
Heart Care Foundation
ClinicalTrials.gov Identifier:
NCT01969890
First received: October 22, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Anterior Acute Myocardial Infarction
Left Ventricular Systolic Dysfunction
Drug: G-CSF administration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study on STem cElls Mobilization in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Heart Care Foundation:

Primary Outcome Measures:
  • The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure. [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - All cause death and cardiovascular events [ Time Frame: two years ] [ Designated as safety issue: Yes ]

    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.


Other Outcome Measures:
  • Safety endpoints - Incidence and severity of bleeding complications, - incidence of malignancy, - incidence and intensity of serious adverse events (SAEs) and adverse drug reactions (ADRs) [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1530
Study Start Date: October 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-CSF
Zarzio - 5 microg/kg bis in die for 6 days
Drug: G-CSF administration
Zarzio - 5 microg/kg bis in die for 6 days
Other Name: Zarzio
No Intervention: standard therapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969890

Contacts
Contact: Aldo P. Maggioni, MD +39-055-5101361 centrostudi@anmco.it

  Hide Study Locations
Locations
Italy
Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC Recruiting
Ancona, AN, Italy, 60122
Contact: Gian Piero Perna, MD    +39-071-5965348    gp.perna@ospedaliriuniti.marche.it   
Principal Investigator: Gian Piero Perna, MD         
Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia Not yet recruiting
Ascoli Piceno, AP, Italy, 63100
Contact: Luciano Moretti, MD    +39-0736-358228    l.moretti@asl13.marche.it   
Principal Investigator: Luciano Moretti, MD         
Ospedale San Donato - UO Cardiologia Recruiting
Arezzo, AR, Italy, 52100
Contact: Leonardo Bolognese, MD    +39-0575-255520    leonardobolognese@hotmail.com   
Principal Investigator: Leonardo Bolognese, MD         
AORN Giuseppe Moscati - UO Cardiologia-UTIC Not yet recruiting
Avellino, AV, Italy, 83100
Contact: Giovanni Stanco, MD    +39-0825-203727    cardiologia.av@tin.it   
Principal Investigator: Giovanni Stanco, MD         
Humanitas Gavazzeni - UO Cardiologia Recruiting
Bergamo, BG, Italy, 24125
Contact: Antonino Pitì, MD    +39-035-4204274    antonino.piti@gavazzeni.it   
Principal Investigator: Antonino Pitì, MD         
Ospedale Bolognini - Divisione di Cardiologia Recruiting
Seriate, BG, Italy, 24068
Contact: Maurizio Tespili, MD    +39-035-3063319    cardiologia.seriate@bolognini.bg.it   
Principal Investigator: Maurizio Tespili, MD         
Ospedale Maggiore - UO Cardiologia Recruiting
Bologna, BO, Italy, 40133
Contact: Giuseppe Di Pasquale, MD    +39-051-6478202    giuseppe.dipasquale@ausl.bologna.it   
Principal Investigator: Gianni Casella, MD         
Ospedale Sant'Elia - Cardiologia-UTIC Not yet recruiting
Caltanissetta, CL, Italy, 93100
Contact: Salvatore Giglia, MD    +39-0934-559113    salvatoregiglia@gmail.com   
Principal Investigator: Salvatore Giglia, MD         
Ospedale Moriggia Pelascini - UO Cardiologia Recruiting
Gravedona, CO, Italy, 22015
Contact: Alessandro Politi, MD    +39-03244-92357    politiarea@tiscali.it   
Principal Investigator: Alessandro Politi, MD         
Ospedale Sant'Anna - UOC Cardiologia Recruiting
San Fermo della Battaglia, CO, Italy, 22020
Contact: Carlo Campana, MD    +39-031-5859482    carlo.campana@hsacomo.org   
Principal Investigator: Carlo Campana, MD         
Ospedale Maggiore - UO Cardiologia e UTIC Recruiting
Crema, CR, Italy, 26013
Contact: Giuseppe Inama, MD    +39-0373-280033    cardiologia@hcrema.it   
Principal Investigator: Michele Cacucci, MD         
Istituti Ospitalieri - UO Cardiologia Recruiting
Cremona, CR, Italy, 26100
Contact: Salvatore Pirelli, MD    +39-0372-405332    cardio.aioc@e-cremona.it   
Principal Investigator: Salvatore Pirelli, MD         
AOU Careggi - Cardiologia Generale 1 Recruiting
Firenze, FI, Italy, 50134
Contact: Gian Franco Gensini, MD    +39-055-7947549    gianfranco.gensini@unifi.it   
Principal Investigator: Serafina Valente, MD         
IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia Not yet recruiting
Genova, GE, Italy, 16132
Contact: Francesco Chiarella, MD    +39-010-5553448    francesco.chiarella@hsanmartino.it   
Principal Investigator: Francesco Chiarella, MD         
Ospedale della Misericordia - UO Cardiologia Recruiting
Grosseto, GR, Italy, 58100
Contact: Silva Severi, MD    +39-0564-485337    s.severi@usl9.toscana.it   
Principal Investigator: Paola Pasqualini, MD         
Presidio Ospedaliero - UO Cardiologia Not yet recruiting
Sanremo, IM, Italy, 18038
Contact: Riccardo Picca Nicolino, MD    +39-0184-536311    r.piccanicolino@asl1.liguria.it   
Principal Investigator: Matteo Vercellino, MD         
Ospedale Alessandro Manzoni - SCD Cardiologia Recruiting
Lecco, LC, Italy, 23900
Contact: Luigi Piatti, MD    +39-0341-489495    l.piatti@ospedale.lecco.it   
Principal Investigator: Felice Achilli, MD         
Sub-Investigator: Cristina Malafronte, MD         
Ospedale Campo Marte - UO Cardiologia Recruiting
Lucca, LU, Italy, 55100
Contact: Francesco M. Bovenzi, MD    +39-0583-449515    f.bovenzi@usl2.toscana.it   
Principal Investigator: Francesco M. Bovenzi, MD         
Ospedale di Circolo - UOC Cardiologia - UTIC Recruiting
Desio, MB, Italy, 20832
Contact: Enrico Planca, MD    +39-0362-383207    segreteriacardiologiadesio@aovimercate.org   
Principal Investigator: Nadia Mollichelli, MD         
Ospedale San Gerardo - UO Cardiologia UTIC Recruiting
Monza, MB, Italy, 20900
Contact: Felice Achilli, MD    +39-039-2333304    uo.cardiologia@hsgerardo.org   
Principal Investigator: Laura F. Valagussa, MD         
Ospedale Bassini - UO Cardiologia e UTIC Recruiting
Cinisello Balsamo, MI, Italy, 20092
Contact: Francesco M. Gentile, MD    +39-02-57998268    francesco.gentile@icp.mi.it   
Principal Investigator: Francesco M. Gentile, MD         
Ospedale Civile - UTIC - Cardiologia Recruiting
Legnano, MI, Italy, 20025
Contact: Stefano De Servi, MD    +39-0331-449229    stefano.deservi@ao-legnano.it   
Principal Investigator: Stefano De Servi, MD         
Ospedale San Carlo Borromeo - Cardiologia UCC Not yet recruiting
Milano, MI, Italy, 20153
Contact: Marco Bernasconi, MD    +39-02-40222943    marc.bernasconi@alice.it   
Principal Investigator: Lidia Squadroni, MD         
Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC Recruiting
Milano, MI, Italy, 20121
Contact: Romano G. Seregni, MD    +39-02-63632275    romano.seregni@fbf.milano.it   
Principal Investigator: Marco Negrini, MD         
Ospedale Niguarda - Cardiologia 1 - Emodinamica Not yet recruiting
Milano, MI, Italy, 20162
Contact: Silvio Klugmann, MD    +39-02-64442308    cardio1degasperis@ospedaleniguarda.it   
Principal Investigator: Antonio Mafrici, MD         
Ospedale San Paolo - Divisione di Cardiologia Recruiting
Milano, MI, Italy, 20142
Contact: Federico Lombardi, MD    +39-02-81844261    federico.lombardi@unimi.it   
Principal Investigator: Carlo Sponzilli, MD         
Ospedale San Luca - Centro Auxologico - UO Cardiologia Recruiting
Milano, MI, Italy, 20149
Contact: Gianfranco Parati, MD    +39-02-619112799    degenza7@auxologico.it   
Principal Investigator: Giovanni B. Perego, MD         
Ospedale L. Sacco - Divisione di Cardiologia Not yet recruiting
Milano, MI, Italy, 20157
Contact: Maurizio Viecca, MD    +39-02-39042539    viecca.maurizio@hsacco.it   
Principal Investigator: Alessandro Colombo, MD         
Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC Recruiting
Milano, MI, Italy, 20138
Contact: Giancarlo Marenzi, MD    +39-02-58002015    unita.coronarica@cardiologicomonzino.it   
Principal Investigator: Giulio Pompilio, MD         
Ospedale Maggiore Policlinico - Divisione di Cardiologia Recruiting
Milano, MI, Italy, 20122
Contact: Fabio Magrini, MD    +39-02-55033504    cardiol@policlinico.mi.it   
Principal Investigator: Luca Mircoli, MD         
Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC Recruiting
Rozzano, MI, Italy, 20089
Contact: Patrizia Presbitero, MD    +39-02-82243601    patrizia.presbitero@humanitas.it   
Principal Investigator: Elena Corrada, MD         
Presidio Ospedaliero Carlo Poma - UO Cardiologia Not yet recruiting
Mantova, MN, Italy, 46100
Contact: Roberto Zanini, MD    +39-0376-201315    cardiologia.mantova@aopoma.it   
Principal Investigator: Roberto Zanini, MD         
Ospedale San Francesco - Cardiologia UTIC Recruiting
Nuoro, NU, Italy, 08100
Contact: Gavino Casu, MD    +39-0784-240237    segreteriacardiologia@aslnuoro.it   
Principal Investigator: Gavino Casu, MD         
Ospedale Giovanni Paolo II - UTIC Cardiologia Recruiting
Olbia, OT, Italy, 07026
Contact: Rosa Anna Maria Pes, MD    +39-0789-552975    rpes@aslolbia.it   
Principal Investigator: Rosa Anna Maria Pes, MD         
Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia Recruiting
Piacenza, PC, Italy, 29100
Contact: Giovanni Q. Villani, MD    +39-0523-303212    gqvillani@live.it   
Principal Investigator: Giovanni Q. Villani, MD         
Azienda Ospedaliera Padova - Clinica Cardiologica Recruiting
Padova, PD, Italy, 35128
Contact: Sabino Iliceto, MD    +39-049-8211844    sabino.iliceto@unipd.it   
Principal Investigator: Luisa Cacciavillani, MD         
AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello Not yet recruiting
Pisa, PI, Italy, 56124
Contact: Mario Marzilli, MD    +39-050-995302    cardio1.univ@ao-pisa.toscana.it   
Principal Investigator: Mario Marzilli, MD         
Fondazione IRCCS Policlinico San Matteo - Card. con UCC-Lab. Ricerca Sperim. Card. Not yet recruiting
Pavia, PV, Italy, 27100
Contact: Peter J. Schwartz, MD    +39-0382-503972    peter.schwartz@unipv.it   
Principal Investigator: Gaetano De Ferrari, MD         
Arcispedale Santa Maria Nuova - UO Degenza Cardiologica Recruiting
Reggio Emilia, RE, Italy, 42100
Contact: Stefano Savonitto, MD    +39-0522-296434    stefano.savonitto@asmn.re.it   
Principal Investigator: Stefano Savonitto, MD         
AO San Giovanni Addolorata - Cardiologia 2 Recruiting
Roma, RM, Italy, 00184
Contact: Francesco Prati, MD    +39-06-77055330    fprati@hsangiovanni.roma.it   
Principal Investigator: Maria Luisa Finocchiaro, MD         
Ospedale Infermi - UO Cardiologia Recruiting
Rimini, RN, Italy, 47900
Contact: Giancarlo Piovaccari, MD    +39-0541-705440    dipcardio@auslrn.net   
Principal Investigator: Andrea Santarelli, MD         
AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC Not yet recruiting
Salerno, SA, Italy, 84131
Contact: Rosario Farina, MD    +39-089-673136    rosario.farina@sangiovannieruggi.it   
Principal Investigator: Rosario Farina, MD         
AOU San Giovanni Battista - SCDU Cardiologia 1 Recruiting
Torino, TO, Italy, 10126
Contact: Fiorenzo Gaita, MD    +39-011-6335570    fiorenzo.gaita@gmail.com,fiorenzo.gaita@unito.it   
Principal Investigator: Fiorenzo Gaita, MD         
AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara Recruiting
Trieste, TS, Italy, 34149
Contact: Gianfranco Sinagra, MD    +39-040-3994477    gianfranco.sinagra@aots.sanita.fvg.it   
Principal Investigator: Gianfranco Sinagra, MD         
Ospedale Ca' Foncello - UOC Cardiologia Recruiting
Treviso, TV, Italy, 31100
Contact: Zoran Olivari, MD    +39-0422-322767    zolivari@ulss.tv.it   
Principal Investigator: Zoran Olivari, MD         
Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia Recruiting
Busto Arsizio, VA, Italy, 21052
Contact: Andrea Macchi, MD    +39-0331-699587    amacchi@aobusto.it   
Principal Investigator: Andrea Macchi, MD         
Presidio Ospedaliero di Saronno - UOC Cardiologia Recruiting
Saronno, VA, Italy, 21047
Contact: Daniele Nassiacos, MD    +39-02/9613459    nassidan@alice.it   
Principal Investigator: Daniele Nassiacos, MD         
Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche Not yet recruiting
Varese, VA, Italy, 21100
Contact: Alberto Limido, MD    +39-0332-278385    alberto.limido@ospedale.varese.it   
Principal Investigator: Alberto Limido, MD         
Ospedale dell'Angelo - UO Cardiologia Recruiting
Mestre, VE, Italy, 30174
Contact: Fausto Rigo, MD    +39-041-9657201    fausto.rigo@ulss12.ve.it   
Principal Investigator: Guerrino Zuin, MD         
Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica Recruiting
Viterbo, VT, Italy, 01100
Contact: Luigi Sommariva, MD    +39-0761-339458    l.sommariva@asl.vt.it   
Principal Investigator: Luigi Sommariva, MD         
AOU Federico II - UTIC Not yet recruiting
Napoli, Italy, 80131
Contact: Bruno Trimarco, MD    +39-081-7462231    trimarco@unina.it   
Principal Investigator: Bruno Trimarco, MD         
AORN Cardarelli - UO SC Cardiologia con UTIC Recruiting
Napoli, Italy, 80131
Contact: Ciro Mauro, MD    +39-081-5586758    ciro.mauro3@tin.it   
Principal Investigator: Ciro Mauro, MD         
AO Univ. Maggiore della Carità - Cardiologia 2 Recruiting
Novara, Italy, 28100
Contact: Angelo S. Bongo, MD    +39-0321-3733442    a.s.bongo@libero.it   
Principal Investigator: Angelo S. Bongo, MD         
Sponsors and Collaborators
Heart Care Foundation
A. Manzoni Hospital
Centro Cardiologico Monzino
Investigators
Study Chair: Felice Achilli, MD Ospedale Alessandro Manzoni - Lecco
Study Chair: Giulio Pompilio, MD Centro Cardiologico Monzino - Milano
  More Information

No publications provided

Responsible Party: Heart Care Foundation
ClinicalTrials.gov Identifier: NCT01969890     History of Changes
Other Study ID Numbers: G112
Study First Received: October 22, 2013
Last Updated: March 17, 2014
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ventricular Dysfunction, Left
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ventricular Dysfunction

ClinicalTrials.gov processed this record on August 19, 2014