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

This study has suspended participant recruitment.
(Upon DSMC suggestion due to a too low enrollment rate.)
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: July 19, 2016
Last verified: March 2015
  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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

  Hide Study Locations
Locations
Italy
Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC
Ancona, AN, Italy, 60122
Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia
Ascoli Piceno, AP, Italy, 63100
Ospedale San Donato - UO Cardiologia
Arezzo, AR, Italy, 52100
AORN Giuseppe Moscati - UO Cardiologia-UTIC
Avellino, AV, Italy, 83100
Humanitas Gavazzeni - UO Cardiologia
Bergamo, BG, Italy, 24125
Ospedale Bolognini - Divisione di Cardiologia
Seriate, BG, Italy, 24068
Ospedale Maggiore - UO Cardiologia
Bologna, BO, Italy, 40133
Ospedale Sant'Elia - Cardiologia-UTIC
Caltanissetta, CL, Italy, 93100
Ospedale Moriggia Pelascini - UO Cardiologia
Gravedona, CO, Italy, 22015
Ospedale Sant'Anna - UOC Cardiologia
San Fermo della Battaglia, CO, Italy, 22020
Ospedale Maggiore - UO Cardiologia e UTIC
Crema, CR, Italy, 26013
Istituti Ospitalieri - UO Cardiologia
Cremona, CR, Italy, 26100
AOU Careggi - Cardiologia Generale 1
Firenze, FI, Italy, 50134
IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia
Genova, GE, Italy, 16132
Ospedale della Misericordia - UO Cardiologia
Grosseto, GR, Italy, 58100
Presidio Ospedaliero - UO Cardiologia
Sanremo, IM, Italy, 18038
Ospedale Alessandro Manzoni - SCD Cardiologia
Lecco, LC, Italy, 23900
Ospedale Campo Marte - UO Cardiologia
Lucca, LU, Italy, 55100
Ospedale di Circolo - UOC Cardiologia - UTIC
Desio, MB, Italy, 20832
Ospedale San Gerardo - UO Cardiologia UTIC
Monza, MB, Italy, 20900
Ospedale Bassini - UO Cardiologia e UTIC
Cinisello Balsamo, MI, Italy, 20092
Ospedale Civile - UTIC - Cardiologia
Legnano, MI, Italy, 20025
Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC
Milano, MI, Italy, 20121
Ospedale Maggiore Policlinico - Divisione di Cardiologia
Milano, MI, Italy, 20122
Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC
Milano, MI, Italy, 20138
Ospedale Niguarda - Cardiologia 1 - Emodinamica
Milano, MI, Italy, 20162
Ospedale San Luca - Centro Auxologico - UO Cardiologia
Milano, MI, Italy, 20149
Ospedale San Carlo Borromeo - Cardiologia UCC
Milano, MI, Italy, 20153
Ospedale L. Sacco - Divisione di Cardiologia
Milano, MI, Italy, 20157
Ospedale San Paolo - Divisione di Cardiologia
Milano, MI, Italy, 20142
Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC
Rozzano, MI, Italy, 20089
Presidio Ospedaliero Carlo Poma - UO Cardiologia
Mantova, MN, Italy, 46100
Ospedale San Francesco - Cardiologia UTIC
Nuoro, NU, Italy, 08100
Ospedale Giovanni Paolo II - UTIC Cardiologia
Olbia, OT, Italy, 07026
Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia
Piacenza, PC, Italy, 29100
Azienda Ospedaliera Padova - Clinica Cardiologica
Padova, PD, Italy, 35128
AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello
Pisa, PI, Italy, 56124
Fondazione IRCCS Policlinico San Matteo - Card. con UCC-Lab. Ricerca Sperim. Card.
Pavia, PV, Italy, 27100
Arcispedale Santa Maria Nuova - UO Degenza Cardiologica
Reggio Emilia, RE, Italy, 42100
AO San Giovanni Addolorata - Cardiologia 2
Roma, RM, Italy, 00184
Ospedale Infermi - UO Cardiologia
Rimini, RN, Italy, 47900
AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC
Salerno, SA, Italy, 84131
AOU San Giovanni Battista - SCDU Cardiologia 1
Torino, TO, Italy, 10126
AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara
Trieste, TS, Italy, 34149
Ospedale Ca' Foncello - UOC Cardiologia
Treviso, TV, Italy, 31100
Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia
Busto Arsizio, VA, Italy, 21052
Presidio Ospedaliero di Saronno - UOC Cardiologia
Saronno, VA, Italy, 21047
Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche
Varese, VA, Italy, 21100
Ospedale dell'Angelo - UO Cardiologia
Mestre, VE, Italy, 30174
Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica
Viterbo, VT, Italy, 01100
AORN Cardarelli - UO SC Cardiologia con UTIC
Napoli, Italy, 80131
AOU Federico II - UTIC
Napoli, Italy, 80131
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
  More Information

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: July 19, 2016
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on July 26, 2016