Phase III multicenter trial comparing the efficacy of 2% dodecafluoropentane emulsion (EchoGen) and sonicated 5% human albumin (Albunex) as ultrasound contrast agents in patients with suboptimal echocardiograms
Autor: | Allan L. Klein, Julio E. Pérez, Elizabeth Klodas, David Abrahamson, Anthony N. DeMaria, Julio A. Panza, James L. Weiss, Dalane W. Kitzman, Elyse Foster, Benjamin F. Byrd, Paul A. Grayburn, Gerard P. Aurigemma, David J Sahn, Jerald L Cohen, Joel S. Raichlen, Stuart A Jacobson, Douglas S. Segar, Terrence C. Hack, Manni A Vannan, Steven G Chrysant, Michael H. Picard |
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Jazyk: | angličtina |
Předmět: |
Adult
Male medicine.medical_specialty Heart Diseases Heart Ventricles Contrast Media Sensitivity and Specificity law.invention Randomized controlled trial law Internal medicine Multicenter trial medicine Humans Single-Blind Method In patient Aged Fluorocarbons business.industry Ultrasound Human albumin Middle Aged Active control Surgery Clinical trial medicine.anatomical_structure Echocardiography Ventricle Injections Intravenous Cardiology Emulsions Female business Cardiology and Cardiovascular Medicine Endocardium |
Zdroj: | Journal of the American College of Cardiology. (1):230-236 |
ISSN: | 0735-1097 |
DOI: | 10.1016/S0735-1097(98)00219-8 |
Popis: | Objectives. This study was performed to compare the safety and efficacy of intravenous 2% dodecafluoropentane (DDFP) emulsion (EchoGen) with that of active control (sonicated human albumin [Albunex]) for left ventricular (LV) cavity opacification in adult patients with a suboptimal echocardiogram.Background. The development of new fluorocarbon-based echocardiographic contrast agents such as DDFP has allowed opacification of the left ventricle after peripheral venous injection. We hypothesized that DDFP was clinically superior to the Food and Drug Administration–approved active control.Methods. This was a Phase III, multicenter, single-blind, active controlled trial. Sequential intravenous injections of active control and DDFP were given 30 min apart to 254 patients with a suboptimal echocardiogram, defined as one in which the endocardial borders were not visible in at least two segments in either the apical two- or four-chamber views. Studies were interpreted in blinded manner by two readers and the investigators.Results. Full or intermediate LV cavity opacification was more frequently observed after DDFP than after active control (78% vs. 31% for reader A; 69% vs. 34% for reader B; 83% vs. 55% for the investigators, p < 0.0001). LV cavity opacification scores were higher with DDFP (2.0 to 2.5 vs. 1.1 to 1.5, p < 0.0001). Endocardial border delineation was improved by DDFP in 88% of patients versus 45% with active control (p < 0.001). Similar improvement was seen for duration of contrast effect, salvage of suboptimal echocardiograms, diagnostic confidence and potential to affect patient management. There was no difference between agents in the number of patients with adverse events attributed to the test agent (9% for DDFP vs. 6% for active control, p = 0.92).Conclusions. This Phase III multicenter trial demonstrates that DDFP is superior to sonicated human albumin for LV cavity opacification, endocardial border definition, duration of effect, salvage of suboptimal echocardiograms, diagnostic confidence and potential to influence patient management. The two agents had similar safety profiles. |
Databáze: | OpenAIRE |
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