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

This study has been completed.
Sponsor:
Collaborators:
Wilhelm Sander Foundation
Schulz Foundation
Else Kröner Fresenius Foundation
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00126100
First received: August 1, 2005
Last updated: November 23, 2007
Last verified: November 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 1, 2005
Last Updated: November 23, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
Stem Cells

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

ClinicalTrials.gov processed this record on May 16, 2013