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

This study is currently recruiting participants.
Verified March 2014 by Heart Care Foundation
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: March 17, 2014
Last verified: March 2014
  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
Zarzio - 5 microg/kg bis in die for 6 days
Drug: G-CSF administration
Zarzio - 5 microg/kg bis in die for 6 days
Other Name: Zarzio
No Intervention: standard therapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01969890

Contacts
Contact: Aldo P. Maggioni, MD +39-055-5101361 centrostudi@anmco.it

  Show 53 Study Locations
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

No publications provided

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: March 17, 2014
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on April 23, 2014