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

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: G-CSF Granulocyte-Colony Stimulating Factor; Other: Placebo

• Registration Number: NCT00126100
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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 mechanical reperfusion reduces infarct size.

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.

Study Timeline

• Study Start: 2004-02
• Study Completion: 2005-07
• Study First Submitted: 2005-08-01
• Study First Submitted QC: 2005-08-01
• Study First Posted: 2005-08-02
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-23
• Last Update Posted: 2007-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	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.
2	Placebo	Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.

Primary Outcome Measures

Name	Time	Method
Reduction of infarct size (measured by Tc-sestamibi scintigraphy)	measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	Left ventricular ejection fraction
Incidence of angiographic restenosis	6 months

Trial Locations

Locations (2)

Deutsches Herzzentrum; 🇩🇪 Munich, Germany

671. Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Germany