STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial
- Conditions
- Anterior Acute Myocardial InfarctionLeft Ventricular Systolic Dysfunction
- Interventions
- Registration Number
- NCT01969890
- Lead Sponsor
- Heart Care Foundation
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 532
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G-CSF administration G-CSF administration Granulocyte Colony-Stimulating Factor (G-CSF) administration - 5 microg/kg subcutaneous every 12 hours for 6 days
- Primary Outcome Measures
Name Time Method The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure. two years
- Secondary Outcome Measures
Name Time Method - 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.
Trial Locations
- Locations (53)
AORN Cardarelli - UO SC Cardiologia con UTIC
🇮🇹Napoli, Italy
AOU Federico II - UTIC
🇮🇹Napoli, Italy
AO Univ. Maggiore della Carità - Cardiologia 2
🇮🇹Novara, Italy
Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC
🇮🇹Ancona, AN, Italy
Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia
🇮🇹Ascoli Piceno, AP, Italy
Ospedale San Donato - UO Cardiologia
🇮🇹Arezzo, AR, Italy
AORN Giuseppe Moscati - UO Cardiologia-UTIC
🇮🇹Avellino, AV, Italy
Ospedale Bolognini - Divisione di Cardiologia
🇮🇹Seriate, BG, Italy
Ospedale Maggiore - UO Cardiologia
🇮🇹Bologna, BO, Italy
Ospedale Moriggia Pelascini - UO Cardiologia
🇮🇹Gravedona, CO, Italy
Ospedale Maggiore - UO Cardiologia e UTIC
🇮🇹Crema, CR, Italy
AOU Careggi - Cardiologia Generale 1
🇮🇹Firenze, FI, Italy
IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia
🇮🇹Genova, GE, Italy
Ospedale della Misericordia - UO Cardiologia
🇮🇹Grosseto, GR, Italy
Ospedale Alessandro Manzoni - SCD Cardiologia
🇮🇹Lecco, LC, Italy
Ospedale Campo Marte - UO Cardiologia
🇮🇹Lucca, LU, Italy
Ospedale San Gerardo - UO Cardiologia UTIC
🇮🇹Monza, MB, Italy
Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC
🇮🇹Rozzano, MI, Italy
Presidio Ospedaliero Carlo Poma - UO Cardiologia
🇮🇹Mantova, MN, Italy
Ospedale San Francesco - Cardiologia UTIC
🇮🇹Nuoro, NU, Italy
Ospedale Giovanni Paolo II - UTIC Cardiologia
🇮🇹Olbia, OT, Italy
AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara
🇮🇹Trieste, TS, Italy
Istituti Ospitalieri - UO Cardiologia
🇮🇹Cremona, CR, Italy
Ospedale San Luca - Centro Auxologico - UO Cardiologia
🇮🇹Milano, MI, Italy
Ospedale Niguarda - Cardiologia 1 - Emodinamica
🇮🇹Milano, MI, Italy
Ospedale Sant'Elia - Cardiologia-UTIC
🇮🇹Caltanissetta, CL, Italy
Ospedale Sant'Anna - UOC Cardiologia
🇮🇹San Fermo della Battaglia, CO, Italy
Humanitas Gavazzeni - UO Cardiologia
🇮🇹Bergamo, BG, Italy
Presidio Ospedaliero - UO Cardiologia
🇮🇹Sanremo, IM, Italy
Ospedale di Circolo - UOC Cardiologia - UTIC
🇮🇹Desio, MB, Italy
Ospedale Maggiore Policlinico - Divisione di Cardiologia
🇮🇹Milano, MI, Italy
Ospedale Civile - UTIC - Cardiologia
🇮🇹Legnano, MI, Italy
Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC
🇮🇹Milano, MI, Italy
Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC
🇮🇹Milano, MI, Italy
Ospedale Bassini - UO Cardiologia e UTIC
🇮🇹Cinisello Balsamo, MI, Italy
Ospedale San Paolo - Divisione di Cardiologia
🇮🇹Milano, MI, Italy
Ospedale L. Sacco - Divisione di Cardiologia
🇮🇹Milano, MI, Italy
Ospedale San Carlo Borromeo - Cardiologia UCC
🇮🇹Milano, MI, Italy
Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia
🇮🇹Piacenza, PC, Italy
Azienda Ospedaliera Padova - Clinica Cardiologica
🇮🇹Padova, PD, Italy
AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello
🇮🇹Pisa, PI, Italy
Fondazione IRCCS Policlinico San Matteo - Card. con UCC-Lab. Ricerca Sperim. Card.
🇮🇹Pavia, PV, Italy
AO San Giovanni Addolorata - Cardiologia 2
🇮🇹Roma, RM, Italy
Ospedale Infermi - UO Cardiologia
🇮🇹Rimini, RN, Italy
AOU San Giovanni Battista - SCDU Cardiologia 1
🇮🇹Torino, TO, Italy
Arcispedale Santa Maria Nuova - UO Degenza Cardiologica
🇮🇹Reggio Emilia, RE, Italy
AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC
🇮🇹Salerno, SA, Italy
Ospedale Ca' Foncello - UOC Cardiologia
🇮🇹Treviso, TV, Italy
Presidio Ospedaliero di Saronno - UOC Cardiologia
🇮🇹Saronno, VA, Italy
Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia
🇮🇹Busto Arsizio, VA, Italy
Ospedale dell'Angelo - UO Cardiologia
🇮🇹Mestre, VE, Italy
Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche
🇮🇹Varese, VA, Italy
Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica
🇮🇹Viterbo, VT, Italy