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Previous Volume 355:1199-1209 September 21, 2006 Number 12 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Perspective by Schwartz, R. S. Editorial by Rosenzweig, A. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Previous studies have shown improvement in left ventricular function after intracoronary injection of autologous cells derived from bone marrow (BMC) in the acute phase of myocardial infarction. We designed a randomized, controlled trial to further investigate the effects of this treatment.

Methods Patients with acute ST-elevation myocardial infarction of the anterior wall treated with percutaneous coronary intervention were randomly assigned to the group that underwent intracoronary injection 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-gated single-photon-emission computed tomography (SPECT) and echocardiography at baseline and magnetic resonance imaging (MRI) 2 to 3 weeks after the infarction. These procedures were repeated 6 months after the infarction. End points were changes in the left ventricular ejection fraction (LVEF), end-diastolic volume, and infarct size.

Results Of the 50 patients assigned to treatment with mononuclear BMC, 47 underwent intracoronary injection of the cells at a median of 6 days after myocardial infarction. There were 50 patients in the control group. The mean (±SD) change in LVEF, measured with the use of SPECT, between baseline and 6 months after infarction for all patients was 7.6±10.4 percentage points. The effect of BMC treatment on the change in LVEF was an increase of 0.6 percentage point (95% confidence interval [CI], –3.4 to 4.6; P=0.77) on SPECT, an increase of 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 groups did not differ significantly in changes in left ventricular end-diastolic volume or infarct size and had similar rates of adverse events.

Conclusions With the methods used, we found no effects of intracoronary injection of autologous mononuclear BMC on global left ventricular function. (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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