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

Sponsor
Heart Care Foundation (Other)
Overall Status
Terminated
CT.gov ID
NCT01969890
Collaborator
A. Manzoni Hospital (Other), Centro Cardiologico Monzino (Other)
532
Enrollment
53
Locations
2
Arms
55
Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: G-CSF administration
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
532 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Study on STem cElls Mobilization in Acute Myocardial Infarction
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Zarzio

    		•
    No Intervention: standard therapy

    Standard therapy

    Outcome Measures

    Primary Outcome Measures

    1. The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure. [two years]

    Secondary Outcome Measures

    1. - All cause death and cardiovascular events [two years]

      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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC Ancona AN Italy 60122
    2 Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia Ascoli Piceno AP Italy 63100
    3 Ospedale San Donato - UO Cardiologia Arezzo AR Italy 52100
    4 AORN Giuseppe Moscati - UO Cardiologia-UTIC Avellino AV Italy 83100
    5 Humanitas Gavazzeni - UO Cardiologia Bergamo BG Italy 24125
    6 Ospedale Bolognini - Divisione di Cardiologia Seriate BG Italy 24068
    7 Ospedale Maggiore - UO Cardiologia Bologna BO Italy 40133
    8 Ospedale Sant'Elia - Cardiologia-UTIC Caltanissetta CL Italy 93100
    9 Ospedale Moriggia Pelascini - UO Cardiologia Gravedona CO Italy 22015
    10 Ospedale Sant'Anna - UOC Cardiologia San Fermo della Battaglia CO Italy 22020
    11 Ospedale Maggiore - UO Cardiologia e UTIC Crema CR Italy 26013
    12 Istituti Ospitalieri - UO Cardiologia Cremona CR Italy 26100
    13 AOU Careggi - Cardiologia Generale 1 Firenze FI Italy 50134
    14 IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia Genova GE Italy 16132
    15 Ospedale della Misericordia - UO Cardiologia Grosseto GR Italy 58100
    16 Presidio Ospedaliero - UO Cardiologia Sanremo IM Italy 18038
    17 Ospedale Alessandro Manzoni - SCD Cardiologia Lecco LC Italy 23900
    18 Ospedale Campo Marte - UO Cardiologia Lucca LU Italy 55100
    19 Ospedale di Circolo - UOC Cardiologia - UTIC Desio MB Italy 20832
    20 Ospedale San Gerardo - UO Cardiologia UTIC Monza MB Italy 20900
    21 Ospedale Bassini - UO Cardiologia e UTIC Cinisello Balsamo MI Italy 20092
    22 Ospedale Civile - UTIC - Cardiologia Legnano MI Italy 20025
    23 Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC Milano MI Italy 20121
    24 Ospedale Maggiore Policlinico - Divisione di Cardiologia Milano MI Italy 20122
    25 Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC Milano MI Italy 20138
    26 Ospedale San Paolo - Divisione di Cardiologia Milano MI Italy 20142
    27 Ospedale San Luca - Centro Auxologico - UO Cardiologia Milano MI Italy 20149
    28 Ospedale San Carlo Borromeo - Cardiologia UCC Milano MI Italy 20153
    29 Ospedale L. Sacco - Divisione di Cardiologia Milano MI Italy 20157
    30 Ospedale Niguarda - Cardiologia 1 - Emodinamica Milano MI Italy 20162
    31 Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC Rozzano MI Italy 20089
    32 Presidio Ospedaliero Carlo Poma - UO Cardiologia Mantova MN Italy 46100
    33 Ospedale San Francesco - Cardiologia UTIC Nuoro NU Italy 08100
    34 Ospedale Giovanni Paolo II - UTIC Cardiologia Olbia OT Italy 07026
    35 Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia Piacenza PC Italy 29100
    36 Azienda Ospedaliera Padova - Clinica Cardiologica Padova PD Italy 35128
    37 AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello Pisa PI Italy 56124
    38 Fondazione IRCCS Policlinico San Matteo - Card. con UCC-Lab. Ricerca Sperim. Card. Pavia PV Italy 27100
    39 Arcispedale Santa Maria Nuova - UO Degenza Cardiologica Reggio Emilia RE Italy 42100
    40 AO San Giovanni Addolorata - Cardiologia 2 Roma RM Italy 00184
    41 Ospedale Infermi - UO Cardiologia Rimini RN Italy 47900
    42 AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC Salerno SA Italy 84131
    43 AOU San Giovanni Battista - SCDU Cardiologia 1 Torino TO Italy 10126
    44 AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara Trieste TS Italy 34149
    45 Ospedale Ca' Foncello - UOC Cardiologia Treviso TV Italy 31100
    46 Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia Busto Arsizio VA Italy 21052
    47 Presidio Ospedaliero di Saronno - UOC Cardiologia Saronno VA Italy 21047
    48 Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche Varese VA Italy 21100
    49 Ospedale dell'Angelo - UO Cardiologia Mestre VE Italy 30174
    50 Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica Viterbo VT Italy 01100
    51 AORN Cardarelli - UO SC Cardiologia con UTIC Napoli Italy 80131
    52 AOU Federico II - UTIC Napoli Italy 80131
    53 AO Univ. Maggiore della Carità - Cardiologia 2 Novara Italy 28100

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Heart Care Foundation
    ClinicalTrials.gov Identifier:
    NCT01969890
    Other Study ID Numbers:
    • G112
    First Posted:
    Oct 25, 2013
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Feb 3, 2021