Patients with coronary artery disease, suffering from a large myocardial infarction. The loss of viable myocardium initiates a process of adverse left ventricular (LV) remodeling leading to chamber dilatation and contractile dysfunction in many patients. Intracoronary bone marrow cell transfer may represent - for the first time - a therapeutic strategy to enhance LV functional recovery after AMI (our current medical and interventional strategies are only able to limit the damage).
Conditions
Interventions
Product Name: autologous bone marrow
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intracoronary us
Sponsors
Medical School, Dept. of Cardiology and Angiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a first ST-segment elevation myocardial infarction, successful percutaneous coronary intervention (PCI) with stent implantation of the infarct-related artery, hypokinesia or akinesia involving equal to or more than 2/3 of the left ventricular anteroseptal, lateral, and/or inferior wall, as revealed by angiography performed immediately after PCI. And time from symptom onset to reperfusion of >3 hours and baseline LVEF =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Multivessel coronary artery disease requiring repeat PCI or coronary bypass grafting, pulmonary edema or cardiogenic shock (Killip classes III and IV), advanced renal or hepatic disease, pregnancy, documented terminal illness or cancer, pacemaker or ICD. Reinfarction in the myocardial circulatory bed of a documented previous myocardial infarction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypothesis 1: Use of a low amount of BMCs (low dose, 40 mL) for intracoronary therapy improves LV ejection fraction after AMI at 6 months as compared to a blinded control group receiving an intracoronary placebo infusion. Hypothesis 2: The efficacy of irradiated bone marrow cells for intracoronary therapy is superior to no intracoronary bone marrow cell application in a control group concerning improvement of left ventricular ejection fraction after AMI at 6 months. Furthermore, the effect is similar compared to non-irradiated cells.;Secondary Objective: Influence of intracoronary BMC therapy on clinical endpoints: - Major adverse cardiac events (death, recurrent AMI, target vessel revascularization, hospitaliza-tion with heart failure) - Physical capacity as assessed by cardiopulmonary exercise testing - Quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire Influence of intracoronary BMC therapy on parameters of LV remodeling and function in the setting of a multicenter trial: - LV end-diastolic and end-systolic volume indices (as determined by MRI) - Infarct size (MRI); LV mass (MRI); Regional LV function (MRI) - Diastolic LV function (Doppler echocardiography) Influence of intracoronary BMC therapy on LV ejection fraction at 18 months as determined by MRI Influence of intracoronary bone marrow cell therapy on serum and bone marrow markers of inflammation and angiogenesis ;Primary end point(s): Global left ventricular ejection fraction (LVEF) change from baseline (prior to cell transfer) to 6 month follow-up will be the prespecified, primary endpoint of the BOOST-2 trial. | — |
Countries
Germany
Outcome results
None listed