Patients with acute coronary syndrome (NSTEMI) due to coronary artery disease
Conditions
Interventions
Product Name: autologous bone marrow-derived progenitor cells (BMC)
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the
Sponsors
Cardiology, J. W. Goethe University Frankfurt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -NSTEMI, treated with sussessful percutaneous coronary intervention and stent implantation -hemodynamic stability without intravenous catechoamines or mechanical assist within 6 hours after PCI -age 18 to 80 years -written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - STEMI - heart failure (ejection fraction = 2,5 mg/dl) - hepatic disease (GOT > 2 xUNL, spontaneous INR > 1,5) - hematological disorders (anaemia (Hb < 8,5 mg/dl), thrombocytopenia (< 100000), - splenomegaly) - known allergies to Clopidogrel, Heparin, Abciximab - bleeding disorders - GI bleeding within 3 months - major surgery or trauma within 2 months - uncontrolled hypertension - pregnancy - mental retardation - participation in other clinical trial within 30 days - previous stem cell therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Myocardial infarction leads to microvascular dysfunction with consecutively reduced coronary flow reserve, which persists after 4 months. Moreover, recent clinical trials have shown that a reduced coronary flow reserve is associated with adverse outcome in the future. Intracoronary infusion of bone marrow-derived progenitor cells lead to complete normalization of coronary blood flow, as demonstrated by the placebo-controlled, double-blind REPAIR-AMI trial, suggesting increased neovascularization by the infused cells . Therefore, the primary objective of the current trial is to improve coronary flow reserve in patients with NSTEMI by intracoronary infusion of autologous bone marrow-derived mononuclear progenitor cells, compared with a placebo group, in a double-blind way.;Secondary Objective: As secondary endpoints the relative coronary flow reserve, vascular resistences and coronary blood flow will be assessed, as well as cardiovascular events like death, myocardial (re-) infarction, coronary revascularization, and hospitalization for heart failure, and quality of life.;Primary end point(s): Improvement of corornary flow reserve in the infarct artery after 4 months | — |
Countries
Germany
Outcome results
None listed