Enhanced left ventricular endocardial border delineation with an intravenous injection of SonoVue, a new echocardiographic contrast agent: A Europeanmulticenter study

The safety and efficacy of SonoVue (also referred to as BR1), a new contras t agent for delineating endocardial border of the left ventricle after intr avenous administration, was assessed. Two hundred and eighteen patients wit h suspected coronary artery disease undergoing fundamental echocardiography for the assessment of left ventricle were enrolled in a prospective multic enter, single blind, cross-over study with random sequence allocation of fo ur different doses of SonoVue. Endocardial border definition in the apical and parasternal views was scored as 0 = not visible, 1 = barely visible, an d 2 = well visualized before and after contrast enhancement. Analysis was p erformed by two pairs of off-site observers. Safety of SonoVue was also ass essed. Results of our study indicated that the mean improvements in the end ocardial border visualization score were as follows: 3.1 +/- 7.8 (95% CI, 2 .5 and 3.7) for 0.5 ml, 3.4 +/- 8.0 (95% CI, 2.8 and 4.0) for 1 ml, 3.4 +/- 7.9 (95% CI, 2.8 and 4.0) for 2 mi, and 3. 7 +/- 8.0 (95% CI, 3.1 and 4.3) for 4 ml (P < 0.05 for all doses from baseline). Changes from baseline in endocardial visualization scores were also seen in the apical views (P < 0. 05) and they were dose-dependent (P < 0.001). Similar enhancements of endoc ardial visualization scores were observed in the apical views in patients w ith suboptimal baseline echocardiographic images. Diagnostic confidence for assigning a score and image quality also were significantly better followi ng contrast enhancement. No significant changes in the laboratory parameter s and vital signs were noted following contrast enhancement, and the side e ffects were minimal. It was concluded that SonoVue is safe and effective in delineating endocardial border, including in patients with suboptimal base line images.