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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126100
First Posted: August 2, 2005
Last Update Posted: November 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wilhelm Sander Foundation
Schulz Foundation
Else Kröner Fresenius Foundation
Information provided by:
Deutsches Herzzentrum Muenchen
  Purpose
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.

Condition Intervention Phase
Myocardial Infarction Drug: G-CSF Granulocyte-Colony Stimulating Factor Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Reduction of infarct size (measured by Tc-sestamibi scintigraphy) [ Time Frame: measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months ]

Secondary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: Left ventricular ejection fraction ]
  • Incidence of angiographic restenosis [ Time Frame: 6 months ]

Enrollment: 114
Study Start Date: February 2004
Study Completion Date: July 2005
Arms Assigned Interventions
Experimental: 1
Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.
Drug: G-CSF Granulocyte-Colony Stimulating Factor
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 Comparator: 2
Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.
Other: Placebo
Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126100


Locations
Germany
Deutsches Herzzentrum
Munich, Germany, 80636
671. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Wilhelm Sander Foundation
Schulz Foundation
Else Kröner Fresenius Foundation
Investigators
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00126100     History of Changes
Other Study ID Numbers: GE IDE No. I01003
KKF 10-02
KKF 04-03
First Submitted: August 1, 2005
First Posted: August 2, 2005
Last Update Posted: November 26, 2007
Last Verified: November 2007

Keywords provided by Deutsches Herzzentrum Muenchen:
Stem Cells

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs