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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Heart Care Foundation
A. Manzoni Hospital
Centro Cardiologico Monzino
Information provided by (Responsible Party):
Heart Care Foundation Identifier:
First received: October 22, 2013
Last updated: March 26, 2015
Last verified: March 2015
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 administration
Granulocyte Colony-Stimulating Factor (G-CSF) administration - 5 microg/kg subcutaneous every 12 hours for 6 days
Drug: G-CSF administration
Zarzio - 5 microg/kg bis in die for 6 days
Other Name: Zarzio
No Intervention: standard therapy
Standard therapy

Detailed 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.


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

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 identifier: NCT01969890

Contact: Aldo P. Maggioni, MD +39-055-5101361

  Hide Study Locations
Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC Recruiting
Ancona, AN, Italy, 60122
Contact: Gian Piero Perna, MD    +39-071-5965348   
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   
Principal Investigator: Luciano Moretti, MD         
Ospedale San Donato - UO Cardiologia Recruiting
Arezzo, AR, Italy, 52100
Contact: Leonardo Bolognese, MD    +39-0575-255520   
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   
Principal Investigator: Giovanni Stanco, MD         
Humanitas Gavazzeni - UO Cardiologia Recruiting
Bergamo, BG, Italy, 24125
Contact: Antonino Pitì, MD    +39-035-4204274   
Principal Investigator: Antonino Pitì, MD         
Ospedale Bolognini - Divisione di Cardiologia Recruiting
Seriate, BG, Italy, 24068
Contact: Maurizio Tespili, MD    +39-035-3063319   
Principal Investigator: Maurizio Tespili, MD         
Ospedale Maggiore - UO Cardiologia Recruiting
Bologna, BO, Italy, 40133
Contact: Giuseppe Di Pasquale, MD    +39-051-6478202   
Principal Investigator: Gianni Casella, MD         
Ospedale Sant'Elia - Cardiologia-UTIC Not yet recruiting
Caltanissetta, CL, Italy, 93100
Contact: Salvatore Giglia, MD    +39-0934-559113   
Principal Investigator: Salvatore Giglia, MD         
Ospedale Moriggia Pelascini - UO Cardiologia Recruiting
Gravedona, CO, Italy, 22015
Contact: Alessandro Politi, MD    +39-03244-92357   
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   
Principal Investigator: Carlo Campana, MD         
Ospedale Maggiore - UO Cardiologia e UTIC Recruiting
Crema, CR, Italy, 26013
Contact: Giuseppe Inama, MD    +39-0373-280033   
Principal Investigator: Michele Cacucci, MD         
Istituti Ospitalieri - UO Cardiologia Recruiting
Cremona, CR, Italy, 26100
Contact: Salvatore Pirelli, MD    +39-0372-405332   
Principal Investigator: Salvatore Pirelli, MD         
AOU Careggi - Cardiologia Generale 1 Recruiting
Firenze, FI, Italy, 50134
Contact: Gian Franco Gensini, MD    +39-055-7947549   
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   
Principal Investigator: Francesco Chiarella, MD         
Ospedale della Misericordia - UO Cardiologia Recruiting
Grosseto, GR, Italy, 58100
Contact: Silva Severi, MD    +39-0564-485337   
Principal Investigator: Paola Pasqualini, MD         
Presidio Ospedaliero - UO Cardiologia Not yet recruiting
Sanremo, IM, Italy, 18038
Contact: Riccardo Picca Nicolino, MD    +39-0184-536311   
Principal Investigator: Matteo Vercellino, MD         
Ospedale Alessandro Manzoni - SCD Cardiologia Recruiting
Lecco, LC, Italy, 23900
Contact: Luigi Piatti, MD    +39-0341-489495   
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   
Principal Investigator: Francesco M. Bovenzi, MD         
Ospedale di Circolo - UOC Cardiologia - UTIC Recruiting
Desio, MB, Italy, 20832
Contact: Enrico Planca, MD    +39-0362-383207   
Principal Investigator: Nadia Mollichelli, MD         
Ospedale San Gerardo - UO Cardiologia UTIC Recruiting
Monza, MB, Italy, 20900
Contact: Felice Achilli, MD    +39-039-2333304   
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   
Principal Investigator: Francesco M. Gentile, MD         
Ospedale Civile - UTIC - Cardiologia Recruiting
Legnano, MI, Italy, 20025
Contact: Stefano De Servi, MD    +39-0331-449229   
Principal Investigator: Stefano De Servi, MD         
Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC Recruiting
Milano, MI, Italy, 20121
Contact: Romano G. Seregni, MD    +39-02-63632275   
Principal Investigator: Marco Negrini, MD         
Ospedale Maggiore Policlinico - Divisione di Cardiologia Recruiting
Milano, MI, Italy, 20122
Contact: Fabio Magrini, MD    +39-02-55033504   
Principal Investigator: Luca Mircoli, MD         
Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC Recruiting
Milano, MI, Italy, 20138
Contact: Giancarlo Marenzi, MD    +39-02-58002015   
Principal Investigator: Giulio Pompilio, MD         
Ospedale San Paolo - Divisione di Cardiologia Recruiting
Milano, MI, Italy, 20142
Contact: Federico Lombardi, MD    +39-02-81844261   
Principal Investigator: Carlo Sponzilli, MD         
Ospedale San Luca - Centro Auxologico - UO Cardiologia Recruiting
Milano, MI, Italy, 20149
Contact: Gianfranco Parati, MD    +39-02-619112799   
Principal Investigator: Giovanni B. Perego, MD         
Ospedale San Carlo Borromeo - Cardiologia UCC Not yet recruiting
Milano, MI, Italy, 20153
Contact: Marco Bernasconi, MD    +39-02-40222943   
Principal Investigator: Lidia Squadroni, MD         
Ospedale L. Sacco - Divisione di Cardiologia Not yet recruiting
Milano, MI, Italy, 20157
Contact: Maurizio Viecca, MD    +39-02-39042539   
Principal Investigator: Alessandro Colombo, MD         
Ospedale Niguarda - Cardiologia 1 - Emodinamica Not yet recruiting
Milano, MI, Italy, 20162
Contact: Silvio Klugmann, MD    +39-02-64442308   
Principal Investigator: Antonio Mafrici, MD         
Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC Recruiting
Rozzano, MI, Italy, 20089
Contact: Patrizia Presbitero, MD    +39-02-82243601   
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   
Principal Investigator: Roberto Zanini, MD         
Ospedale San Francesco - Cardiologia UTIC Recruiting
Nuoro, NU, Italy, 08100
Contact: Gavino Casu, MD    +39-0784-240237   
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   
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   
Principal Investigator: Giovanni Q. Villani, MD         
Azienda Ospedaliera Padova - Clinica Cardiologica Recruiting
Padova, PD, Italy, 35128
Contact: Sabino Iliceto, MD    +39-049-8211844   
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   
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   
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   
Principal Investigator: Stefano Savonitto, MD         
AO San Giovanni Addolorata - Cardiologia 2 Recruiting
Roma, RM, Italy, 00184
Contact: Francesco Prati, MD    +39-06-77055330   
Principal Investigator: Maria Luisa Finocchiaro, MD         
Ospedale Infermi - UO Cardiologia Recruiting
Rimini, RN, Italy, 47900
Contact: Giancarlo Piovaccari, MD    +39-0541-705440   
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   
Principal Investigator: Rosario Farina, MD         
AOU San Giovanni Battista - SCDU Cardiologia 1 Recruiting
Torino, TO, Italy, 10126
Contact: Fiorenzo Gaita, MD    +39-011-6335570,   
Principal Investigator: Fiorenzo Gaita, MD         
AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara Recruiting
Trieste, TS, Italy, 34149
Contact: Gianfranco Sinagra, MD    +39-040-3994477   
Principal Investigator: Gianfranco Sinagra, MD         
Ospedale Ca' Foncello - UOC Cardiologia Recruiting
Treviso, TV, Italy, 31100
Contact: Zoran Olivari, MD    +39-0422-322767   
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   
Principal Investigator: Andrea Macchi, MD         
Presidio Ospedaliero di Saronno - UOC Cardiologia Recruiting
Saronno, VA, Italy, 21047
Contact: Daniele Nassiacos, MD    +39-02/9613459   
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   
Principal Investigator: Alberto Limido, MD         
Ospedale dell'Angelo - UO Cardiologia Recruiting
Mestre, VE, Italy, 30174
Contact: Fausto Rigo, MD    +39-041-9657201   
Principal Investigator: Guerrino Zuin, MD         
Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica Recruiting
Viterbo, VT, Italy, 01100
Contact: Luigi Sommariva, MD    +39-0761-339458   
Principal Investigator: Luigi Sommariva, MD         
AORN Cardarelli - UO SC Cardiologia con UTIC Recruiting
Napoli, Italy, 80131
Contact: Ciro Mauro, MD    +39-081-5586758   
Principal Investigator: Ciro Mauro, MD         
AOU Federico II - UTIC Not yet recruiting
Napoli, Italy, 80131
Contact: Bruno Trimarco, MD    +39-081-7462231   
Principal Investigator: Bruno Trimarco, MD         
AO Univ. Maggiore della Carità - Cardiologia 2 Recruiting
Novara, Italy, 28100
Contact: Angelo S. Bongo, MD    +39-0321-3733442   
Principal Investigator: Angelo S. Bongo, MD         
Sponsors and Collaborators
Heart Care Foundation
A. Manzoni Hospital
Centro Cardiologico Monzino
Study Chair: Felice Achilli, MD Ospedale Alessandro Manzoni - Lecco
Study Chair: Giulio Pompilio, MD Centro Cardiologico Monzino - Milano
  More Information

Responsible Party: Heart Care Foundation Identifier: NCT01969890     History of Changes
Other Study ID Numbers: G112 
Study First Received: October 22, 2013
Last Updated: March 26, 2015
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Myocardial Infarction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Ventricular Dysfunction processed this record on May 05, 2016