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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 114
- Locations
- 2
- Primary Endpoint
- Reduction of infarct size (measured by Tc-sestamibi scintigraphy)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.
Intervention: G-CSF Granulocyte-Colony Stimulating Factor (Drug)
2
Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Reduction of infarct size (measured by Tc-sestamibi scintigraphy)
Time Frame: measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months
Secondary Outcomes
- Left ventricular ejection fraction(Left ventricular ejection fraction)
- Incidence of angiographic restenosis(6 months)