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Completed

NCT Number: NCT00126100

Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)

The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

671. Medizinische Klinik, Klinikum rechts der Isar, Munich, Germany

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About this study

Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ST-elevation acute myocardial infarction (5 days before randomization)
  • Successful percutaneous coronary intervention [PCI] (performed within 12 hours from symptom onset)
  • Scintigraphic infarct size >5% of left ventricle
  • Written informed consent

Exclusion criteria

  • Age <18 years or >80 years
  • Congestive heart failure defined as Killip class >2
  • A history of myocardial infarction
  • Electrical or hemodynamic instability
  • Autoimmune diseases
  • Fructose intolerance
  • Malignancies
  • Incompatibility of filgrastim
  • Known or suspected pregnancy

Treatment and study plan

G-CSF Granulocyte-Colony Stimulating Factor

Drug

Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.

Other names: Neupogen (Filograstim), Granocyte (Lenograstim)

Placebo

Other

Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.

Primary outcomes

  1. Reduction of infarct size (measured by Tc-sestamibi scintigraphy)

    Time frame: measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months

Secondary outcomes

  1. Left ventricular ejection fraction

    Time frame: Left ventricular ejection fraction

  2. Incidence of angiographic restenosis

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Else Kröner Fresenius Foundation
  • Schulz Foundation
  • Wilhelm Sander Foundation

Registry information

Official study title

A Randomized Clinical Trial of Stem Cell Mobilization by Granulocyte-Colony-Stimulating Factor in Patients With Acute Myocardial Infarction. Regenerate Vital Myocardium by Vigorous Activation of Bone Marrow Stem Cells (REVIVAL-2) Trial

Important dates

Study start
2004
Study completion
2005
First posted
Aug 2, 2005
Registry last updated
Nov 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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