This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(\</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
375
Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique
Cardiovascular Research Centre VZW
Aalst, Belgium
Katholieke Universiteit Leuven
Leuven, Belgium
Fakultni Nemocnice BRNO
Brno, Czechia
Region Hovedstaden
Copenhagen, Denmark
Kuopio University Hospital
Kuopio, Finland
Zentralklinik Bad Berka
Time from randomization to all-cause death
Time frame: for an average of 3 years
Time from randomization to cardiac death
Time frame: for an average of 3 years
time from randomization to cardiovascular rehospitalisation
time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias
Time frame: for an average of 3 years
incidence and severity of adverse events
Time frame: for an average of 3 years
bleeding by BARC definition
Time frame: for an average of 3 years
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Bad Berka, Germany
Universitätsmedizin Charité Berlin
Berlin, Germany
UniLinikum Bonn
Bonn, Germany
Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie
Düsseldorf, Germany
HELIOS Klinikum Erfurt GmbH
Erfurt, Germany
...and 23 more locations