BACKGROUND: This study was conducted to assess the ability of a new echocardiographic contrast agent, Imagent ( @entity49477 lipid microspheres; Alliance Pharmaceutical Corp., San Diego, CA), to improve @entity8668 ( @entity8668 ) and assessment of segmental wall motion (SWM). This was achieved by analysis of inter-reader agreement by echocardiography and comparison with an independent imaging technique, @entity2996 ( @entity2996 ). METHODS: Two separate, independent, prospective, randomized, controlled, multicenter trials were conducted at 26 centers and included a total of 409 efficacy-evaluable @entity1 . In Study A 206 @entity1 were randomized to receive either Imagent or saline and in Study B, 203 @entity1 received Imagent with a subset imaged by both echocardiography and @entity2996 . All @entity1 were required to have suboptimal baseline images using fundamental imaging. Images were optimized at baseline prior to contrast and the settings maintained post-contrast. Imagent, a suspension of @entity49477 -filled spheres with flexible lipid shells, was administered as an IV bolus at 0.125 mg/kg body weight. Gated @entity2996 studies were performed within 48 hours of dosing in a subset of 26 subjects. Six expert independent blinded readers reviewed unpaired noncontrast and contrast exams and scored @entity8668 and SWM. Analysis of inter-reader agreement was performed by comparing the SWM score (1 to 5) recorded by each reader pair. In addition, unanimity between readers for SWM was evaluated. For comparison to @entity2996 , the results from echo readers 4, 5, and 6 were each compared with a single independent @entity2996 reader. RESULTS: The @entity1 enrolled in these clinical trials displayed markedly suboptimal images with 49% and 71% (Study A and Study B) of the segments determined by the readers to be suboptimal prior to contrast administration. All readers recorded statistically significant (P < 0.0001) improvement in total @entity8668 scores following the administration of Imagent. Comparison of noncontrast SWM scores for each pair of echo readers resulted in agreement in an average of 39%, of segments in Study A, and 31% of the segments in Study B. Use of Imagent improved agreement in SWM scores to 65% in Study A, and 48% of segments in Study B (P < 0.0001) for all reader pairs in both studies. Reader unanimity in SWM scores increased from 13% to 41% of the segments with the administration of Imagent. Blinded review of the noncontrast echo examinations resulted in agreement with @entity2996 derived SWM scores in 15% of the segments. The administration of Imagent improved this agreement to 47%, of the segments (P < pr = 0.0005 for each blinded reader). CONCLUSIONS: Use of Imagent during echocardiographic imaging improves @entity8668 , providing a significant improvement in inter-reader agreement in SWM evaluation with echo and greater than a threefold improvement in SWM scoring accuracy with @entity2996 .

Imagent improves XXXX , inter-reader agreement, and the accuracy of segmental wall motion assessment.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity49477 :: ('MESH:C078626', 'Chemical') :: ['perflexane', 'perfluorohexane'] @entity8668 :: ('MESH:D001882', 'Disease') :: ['EBD', 'endocardial border delineation'] @entity2996 :: ('MESH:C564543', 'Disease') :: ['MRI', 'magnetic resonance imaging']
@entity8668 :: (MESH:D001882,Disease) :: ['endocardial border delineation']
