Status:
COMPLETED
Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Wilhelm Sander Foundation
Schulz Foundation
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 mechanic...
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 infar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00126100
Start Date
February 1 2004
End Date
July 1 2005
Last Update
November 26 2007
Active Locations (2)
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1
Deutsches Herzzentrum
Munich, Germany, 80636
2
671. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675