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Anterior Acute Myocardial InfarctionPhase 3STEM-AMINCT01969890

STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial

A Phase 3 study testing G-CSF administration in people with Anterior Acute Myocardial Infarction and Left Ventricular Systolic Dysfunction, run by Heart Care Foundation at 53 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
G-CSF administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
532 participants
Where
53 sitesItaly
Study dates
Oct 2013to May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 21Show fewer
  • 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.

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Italy53 sites

  • Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC

    Ancona, AN, 60122

  • Ospedale San Donato - UO Cardiologia

    Arezzo, AR, 52100

  • Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia

    Ascoli Piceno, AP, 63100

  • AORN Giuseppe Moscati - UO Cardiologia-UTIC

    Avellino, AV, 83100

  • Humanitas Gavazzeni - UO Cardiologia

    Bergamo, BG, 24125

  • Ospedale Maggiore - UO Cardiologia

    Bologna, BO, 40133

  • Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia

    Busto Arsizio, VA, 21052

  • Ospedale Sant'Elia - Cardiologia-UTIC

    Caltanissetta, CL, 93100

  • Ospedale Bassini - UO Cardiologia e UTIC

    Cinisello Balsamo, MI, 20092

  • Ospedale Maggiore - UO Cardiologia e UTIC

    Crema, CR, 26013

  • Istituti Ospitalieri - UO Cardiologia

    Cremona, CR, 26100

  • Ospedale di Circolo - UOC Cardiologia - UTIC

    Desio, MB, 20832

  • AOU Careggi - Cardiologia Generale 1

    Florence, FI, 50134

  • IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia

    Genova, GE, 16132

  • Ospedale Moriggia Pelascini - UO Cardiologia

    Gravedona, CO, 22015

  • Ospedale della Misericordia - UO Cardiologia

    Grosseto, GR, 58100

  • Ospedale Alessandro Manzoni - SCD Cardiologia

    Lecco, LC, 23900

  • Ospedale Civile - UTIC - Cardiologia

    Legnano, MI, 20025

  • Ospedale Campo Marte - UO Cardiologia

    Lucca, LU, 55100

  • Presidio Ospedaliero Carlo Poma - UO Cardiologia

    Mantua, MN, 46100

  • Ospedale dell'Angelo - UO Cardiologia

    Mestre, VE, 30174

  • Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC

    Milan, MI, 20121

  • Ospedale Maggiore Policlinico - Divisione di Cardiologia

    Milan, MI, 20122

  • Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC

    Milan, MI, 20138

  • Ospedale San Paolo - Divisione di Cardiologia

    Milan, MI, 20142

  • Ospedale San Luca - Centro Auxologico - UO Cardiologia

    Milan, MI, 20149

  • Ospedale San Carlo Borromeo - Cardiologia UCC

    Milan, MI, 20153

  • Ospedale L. Sacco - Divisione di Cardiologia

    Milan, MI, 20157

  • Ospedale Niguarda - Cardiologia 1 - Emodinamica

    Milan, MI, 20162

  • Ospedale San Gerardo - UO Cardiologia UTIC

    Monza, MB, 20900

  • AORN Cardarelli - UO SC Cardiologia con UTIC

    Naples, 80131

  • AOU Federico II - UTIC

    Naples, 80131

  • AO Univ. Maggiore della Carità - Cardiologia 2

    Novara, 28100

  • Ospedale San Francesco - Cardiologia UTIC

    Nuoro, NU, 08100

  • Ospedale Giovanni Paolo II - UTIC Cardiologia

    Olbia, OT, 07026

  • Azienda Ospedaliera Padova - Clinica Cardiologica

    Padova, PD, 35128

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

    Pavia, PV, 27100

  • Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia

    Piacenza, PC, 29100

  • AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello

    Pisa, PI, 56124

  • Arcispedale Santa Maria Nuova - UO Degenza Cardiologica

    Reggio Emilia, RE, 42100

  • Ospedale Infermi - UO Cardiologia

    Rimini, RN, 47900

  • AO San Giovanni Addolorata - Cardiologia 2

    Roma, RM, 00184

  • Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC

    Rozzano, MI, 20089

  • AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC

    Salerno, SA, 84131

  • Ospedale Sant'Anna - UOC Cardiologia

    San Fermo della Battaglia, CO, 22020

  • Presidio Ospedaliero - UO Cardiologia

    Sanremo, IM, 18038

  • Presidio Ospedaliero di Saronno - UOC Cardiologia

    Saronno, VA, 21047

  • Ospedale Bolognini - Divisione di Cardiologia

    Seriate, BG, 24068

  • AOU San Giovanni Battista - SCDU Cardiologia 1

    Torino, TO, 10126

  • Ospedale Ca' Foncello - UOC Cardiologia

    Treviso, TV, 31100

  • AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara

    Trieste, TS, 34149

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

    Varese, VA, 21100

  • Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica

    Viterbo, VT, 01100

Other trials in Italy

About this study

Official title: Phase III Study on STem cElls Mobilization in Acute Myocardial Infarction

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.

Read the 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.

Being tested
G-CSF administration
Medical subject headings
Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G-CSF administrationDrug

    Also called Zarzio

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

Study groups in NCT01969890
Study groupRoleWhat they receive
G-CSF administrationExperimentalGranulocyte Colony-Stimulating Factor (G-CSF) administration - 5 microg/kg subcutaneous every 12 hours for 6 days
Receives: Drug: G-CSF administration
standard therapyNo interventionStandard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: two years

Secondary outcomes (1)

  1. - All cause death and cardiovascular events

    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.

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionMay 2018
  4. Study completionMay 2018

Why it stopped: Upon DSMC suggestion due to a too low enrollment rate.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01969890
Sponsor's protocol ID
G112
Acronym
STEM-AMI
Status last verified
Aug 2018
First submitted
22 Oct 2013
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26386788

  • 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.

    PubMed 31138020

  • 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.

    PubMed 39401872

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing G-CSF administration in people with Anterior Acute Myocardial Infarction and Left Ventricular Systolic Dysfunction, run by Heart Care Foundation at 53 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Upon DSMC suggestion due to a too low enrollment rate.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure. (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01969890, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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