STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial

NCT01969890 | Terminated Phase 3 DMC

• 1 other identifier: G112
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 53

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.

Conditions

Anterior Acute Myocardial Infarction; Left Ventricular Systolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure.

  two years

Secondary Outcomes (1)

• - All cause death and cardiovascular events

  two years

Other Outcomes (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

Study Arms (2)

G-CSF administration

EXPERIMENTAL

Granulocyte Colony-Stimulating Factor (G-CSF) administration - 5 microg/kg subcutaneous every 12 hours for 6 days

Drug: G-CSF administration

standard therapy

NO INTERVENTION

Standard therapy

Interventions

G-CSF administration DRUG

Zarzio - 5 microg/kg bis in die for 6 days

Also known as: Zarzio

G-CSF administration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart Care Foundation: lead
• A. Manzoni Hospital: collaborator
• Centro Cardiologico Monzino: collaborator

Study Sites (53)

Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC

Ancona, AN, 60122, Italy

Location

Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia

Ascoli Piceno, AP, 63100, Italy

Location

Ospedale San Donato - UO Cardiologia

Arezzo, AR, 52100, Italy

Location

AORN Giuseppe Moscati - UO Cardiologia-UTIC

Avellino, AV, 83100, Italy

Location

Humanitas Gavazzeni - UO Cardiologia

Bergamo, BG, 24125, Italy

Location

Ospedale Bolognini - Divisione di Cardiologia

Seriate, BG, 24068, Italy

Location

Ospedale Maggiore - UO Cardiologia

Bologna, BO, 40133, Italy

Location

Ospedale Sant'Elia - Cardiologia-UTIC

Caltanissetta, CL, 93100, Italy

Location

Ospedale Moriggia Pelascini - UO Cardiologia

Gravedona, CO, 22015, Italy

Location

Ospedale Sant'Anna - UOC Cardiologia

San Fermo della Battaglia, CO, 22020, Italy

Location

Ospedale Maggiore - UO Cardiologia e UTIC

Crema, CR, 26013, Italy

Location

Istituti Ospitalieri - UO Cardiologia

Cremona, CR, 26100, Italy

Location

AOU Careggi - Cardiologia Generale 1

Florence, FI, 50134, Italy

Location

IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia

Genova, GE, 16132, Italy

Location

Ospedale della Misericordia - UO Cardiologia

Grosseto, GR, 58100, Italy

Location

Presidio Ospedaliero - UO Cardiologia

Sanremo, IM, 18038, Italy

Location

Ospedale Alessandro Manzoni - SCD Cardiologia

Lecco, LC, 23900, Italy

Location

Ospedale Campo Marte - UO Cardiologia

Lucca, LU, 55100, Italy

Location

Ospedale di Circolo - UOC Cardiologia - UTIC

Desio, MB, 20832, Italy

Location

Ospedale San Gerardo - UO Cardiologia UTIC

Monza, MB, 20900, Italy

Location

Ospedale Bassini - UO Cardiologia e UTIC

Cinisello Balsamo, MI, 20092, Italy

Location

Ospedale Civile - UTIC - Cardiologia

Legnano, MI, 20025, Italy

Location

Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC

Milan, MI, 20121, Italy

Location

Ospedale Maggiore Policlinico - Divisione di Cardiologia

Milan, MI, 20122, Italy

Location

Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC

Milan, MI, 20138, Italy

Location

Ospedale San Paolo - Divisione di Cardiologia

Milan, MI, 20142, Italy

Location

Ospedale San Luca - Centro Auxologico - UO Cardiologia

Milan, MI, 20149, Italy

Location

Ospedale San Carlo Borromeo - Cardiologia UCC

Milan, MI, 20153, Italy

Location

Ospedale L. Sacco - Divisione di Cardiologia

Milan, MI, 20157, Italy

Location

Ospedale Niguarda - Cardiologia 1 - Emodinamica

Milan, MI, 20162, Italy

Location

Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC

Rozzano, MI, 20089, Italy

Location

Presidio Ospedaliero Carlo Poma - UO Cardiologia

Mantova, MN, 46100, Italy

Location

Ospedale San Francesco - Cardiologia UTIC

Nuoro, NU, 08100, Italy

Location

Ospedale Giovanni Paolo II - UTIC Cardiologia

Olbia, OT, 07026, Italy

Location

Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia

Piacenza, PC, 29100, Italy

Location

Azienda Ospedaliera Padova - Clinica Cardiologica

Padua, PD, 35128, Italy

Location

AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello

Pisa, PI, 56124, Italy

Location

Fondazione IRCCS Policlinico San Matteo - Card. con UCC-Lab. Ricerca Sperim. Card.

Pavia, PV, 27100, Italy

Location

Arcispedale Santa Maria Nuova - UO Degenza Cardiologica

Reggio Emilia, RE, 42100, Italy

Location

AO San Giovanni Addolorata - Cardiologia 2

Roma, RM, 00184, Italy

Location

Ospedale Infermi - UO Cardiologia

Rimini, RN, 47900, Italy

Location

AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC

Salerno, SA, 84131, Italy

Location

AOU San Giovanni Battista - SCDU Cardiologia 1

Torino, TO, 10126, Italy

Location

AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara

Trieste, TS, 34149, Italy

Location

Ospedale Ca' Foncello - UOC Cardiologia

Treviso, TV, 31100, Italy

Location

Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia

Busto Arsizio, VA, 21052, Italy

Location

Presidio Ospedaliero di Saronno - UOC Cardiologia

Saronno, VA, 21047, Italy

Location

Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche

Varese, VA, 21100, Italy

Location

Ospedale dell'Angelo - UO Cardiologia

Mestre, VE, 30174, Italy

Location

Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica

Viterbo, VT, 01100, Italy

Location

AORN Cardarelli - UO SC Cardiologia con UTIC

Napoli, 80131, Italy

Location

AOU Federico II - UTIC

Napoli, 80131, Italy

Location

AO Univ. Maggiore della Carità - Cardiologia 2

Novara, 28100, Italy

Location

Related Publications (3)

• Achilli F, Malafronte C, Cesana F, Maggiolini S, Mauro C, De Ferrari GM, Lenatti L, Tespili M, Pasqualini P, Gentile F, Capogrossi MC, Maggioni A, Maseri A, Pontone G, Colombo GI, Pompilio G; STEM-AMI OUTCOME Trial Investigators. Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction: rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial. Am Heart J. 2015 Oct;170(4):652-658.e7. doi: 10.1016/j.ahj.2015.07.005. Epub 2015 Jul 12.

  PMID: 26386788 BACKGROUND

• Achilli F, Pontone G, Bassetti B, Squadroni L, Campodonico J, Corrada E, Facchini C, Mircoli L, Esposito G, Scarpa D, Pidello S, Righetti S, Di Gennaro F, Guglielmo M, Muscogiuri G, Baggiano A, Limido A, Lenatti L, Di Tano G, Malafronte C, Soffici F, Ceseri M, Maggiolini S, Colombo GI, Pompilio G; STEM-AMI OUTCOME CMR Sub-Study Investigators. G-CSF for Extensive STEMI. Circ Res. 2019 Jul 19;125(3):295-306. doi: 10.1161/CIRCRESAHA.118.314617. Epub 2019 May 29.

  PMID: 31138020 BACKGROUND

• Achilli F, Maggiolini S, Madotto F, Bassetti B, Gentile F, Maggioni AP, Colombo GI, Pompilio G; STEM-AMI OUTCOME Trial Investigators. Granulocyte colony-stimulating factor for stem cell mobilisation in acute myocardial infarction: a randomised controlled trial. Heart. 2024 Oct 28;110(22):1316-1326. doi: 10.1136/heartjnl-2024-323926.

  PMID: 39401872 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Felice Achilli, MD

  Ospedale Alessandro Manzoni - Lecco

  STUDY CHAIR

• Giulio Pompilio, MD

  Centro Cardiologico Monzino - Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 25, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 3, 2021

Record last verified: 2018-08

Locations

IT (53)