STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial

NCT01969890 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2021-02-03

No results posted yet for this study

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

Interventions

DRUG

G-CSF administration

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

Sponsors & Collaborators

  • A. Manzoni Hospital

    collaborator OTHER
  • Centro Cardiologico Monzino

    collaborator OTHER
  • Heart Care Foundation

    lead OTHER

Principal Investigators

  • Felice Achilli, MD · Ospedale Alessandro Manzoni - Lecco

  • Giulio Pompilio, MD · Centro Cardiologico Monzino - Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01969890 on ClinicalTrials.gov