Acute Myocardial Infarction Clinical Trial
Official title:
SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction
(SWISS-AMI).
Study population: Patients with acute myocardial infarction, treated with primary PCI.
Objective: To determine whether intracoronary infusion of BMCs improves recovery of left
ventricular function after acute myocardial infarction treated by PCI
Design: Multi-center, randomized, controlled clinical trial with central core lab analysis
for MRI.
Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4
weeks after successful primary PCI
Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months
relative to baseline measured by quantitative MRI.
Secondary Endpoints:
- Change in LVEF at MRI at 12 months
- Change in regional left ventricular wall motion and thickness at 4 and 12 months.
- Change in infarct size at 4 and 12 months as assessed by "delayed enhancement"
technique by MRI
- Analysis of the myocardial infarct size and transmurality, time to PCI and coronary
flow characteristics after PCI as predictor of LV remodeling and change after cell
therapy
- Change in myocardial perfusion at 4 and 12 months
- Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
- Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI,
stroke, hospitalization for cardiac reasons) at 12 months
Interventions:
- Aspiration of 50 ml bone marrow (<24 hours) prior to administration
- Intracoronary balloon-based infusion of 10 ml BMCs
- Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months
Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized
infarct related vessel at day 5-7 or day 21-28.
Control group: Management according to the "state of the art" medical therapy after
successful primary PCI.
Safety: A study independent "safety committee" will analyze the clinical results after the
first 60 patients.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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