Background Previous studies have shown improvement in left ventricularfunction after intracoronary injection of autologous cells derivedfrom bone marrow (BMC) in the acute phase of myocardial infarction.We designed a randomized, controlled trial to further investigatethe effects of this treatment.
Methods Patients with acute ST-elevation myocardial infarctionof the anterior wall treated with percutaneous coronary interventionwere randomly assigned to the group that underwent intracoronaryinjection of autologous mononuclear BMC or to the control group,in which neither aspiration nor sham injection was performed.Left ventricular function was assessed with the use of electrocardiogram-gatedsingle-photon-emission computed tomography (SPECT) and echocardiographyat baseline and magnetic resonance imaging (MRI) 2 to 3 weeksafter the infarction. These procedures were repeated 6 monthsafter the infarction. End points were changes in the left ventricularejection fraction (LVEF), end-diastolic volume, and infarctsize.
Results Of the 50 patients assigned to treatment with mononuclearBMC, 47 underwent intracoronary injection of the cells at amedian of 6 days after myocardial infarction. There were 50patients in the control group. The mean (±SD) changein LVEF, measured with the use of SPECT, between baseline and6 months after infarction for all patients was 7.6±10.4percentage points. The effect of BMC treatment on the changein LVEF was an increase of 0.6 percentage point (95% confidenceinterval [CI], 3.4 to 4.6; P=0.77) on SPECT, an increaseof 0.6 percentage point (95% CI, 2.6 to 3.8; P=0.70)on echocardiography, and a decrease of 3.0 percentage points(95% CI, 0.1 to 6.1; P=0.054) on MRI. The two groupsdid not differ significantly in changes in left ventricularend-diastolic volume or infarct size and had similar rates ofadverse events.
Conclusions With the methods used, we found no effects of intracoronaryinjection of autologous mononuclear BMC on global left ventricularfunction. (ClinicalTrials.gov number, NCT00199823
[ClinicalTrials.gov]
.)
Source Information
From the Departments of Cardiology (K.L., S.A., K.E., A.R., K.F.), Nuclear Medicine (J.G.F.), and Radiology (H.J.S., E.H.), and the Institute of Immunology (T.E., E.T., J.E.B.), Rikshospitalet University Hospital; the Departments of Cardiology (S.S., H.A., A.M., R.B.), Cardiovascular Radiology (M.B.), and Nuclear Medicine (C.M.), and the Unit of Epidemiology and Biostatistics, Center for Clinical Research (M.A.), Ullevål University Hospital; and the Institute for Experimental Medical Research, University of Oslo (A.I., H.K.G.) all in Oslo.
Address reprint requests to Dr. Lunde at the Department of Cardiology, Rikshospitalet University Hospital, 0027 Oslo, Norway, or at ketil.lunde{at}rikshospitalet.no.
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