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

Paul A. Grayburn, James L Weiss, Terrence C. Hack, Elizabeth Klodas, Joel S. Raichlen, Manni A. Vannan, Allan L. Klein, Dalane W. Kitzman, Steven G. Chrysant, Jerald L. Cohen, David Abrahamson, Elyse Foster, Julio E. Perez, Gerard P. Aurigemma, Julio A. Panza, Michael H. Picard, Benjamin F. Byrd, Douglas S. Segar, Stuart A. Jacobson, David J. SahnAnthony N. Demaria

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)230-236
Number of pages7
JournalJournal of the American College of Cardiology
Volume32
Issue number1
DOIs
StatePublished - Jul 1998

Fingerprint

Emulsions
Contrast Media
Multicenter Studies
Albumins
Research Personnel
Safety
Albunex
perfluoropentane
perflenapent
Fluorocarbons
United States Food and Drug Administration
Intravenous Injections
Heart Ventricles
Injections

ASJC Scopus subject areas

  • Nursing(all)

Cite this

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. / Grayburn, Paul A.; Weiss, James L; Hack, Terrence C.; Klodas, Elizabeth; Raichlen, Joel S.; Vannan, Manni A.; Klein, Allan L.; Kitzman, Dalane W.; Chrysant, Steven G.; Cohen, Jerald L.; Abrahamson, David; Foster, Elyse; Perez, Julio E.; Aurigemma, Gerard P.; Panza, Julio A.; Picard, Michael H.; Byrd, Benjamin F.; Segar, Douglas S.; Jacobson, Stuart A.; Sahn, David J.; Demaria, Anthony N.

In: Journal of the American College of Cardiology, Vol. 32, No. 1, 07.1998, p. 230-236.

Research output: Contribution to journalArticle

Grayburn, PA, Weiss, JL, Hack, TC, Klodas, E, Raichlen, JS, Vannan, MA, Klein, AL, Kitzman, DW, Chrysant, SG, Cohen, JL, Abrahamson, D, Foster, E, Perez, JE, Aurigemma, GP, Panza, JA, Picard, MH, Byrd, BF, Segar, DS, Jacobson, SA, Sahn, DJ & Demaria, AN 1998, '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', Journal of the American College of Cardiology, vol. 32, no. 1, pp. 230-236. https://doi.org/10.1016/S0735-1097(98)00219-8
Grayburn, Paul A. ; Weiss, James L ; Hack, Terrence C. ; Klodas, Elizabeth ; Raichlen, Joel S. ; Vannan, Manni A. ; Klein, Allan L. ; Kitzman, Dalane W. ; Chrysant, Steven G. ; Cohen, Jerald L. ; Abrahamson, David ; Foster, Elyse ; Perez, Julio E. ; Aurigemma, Gerard P. ; Panza, Julio A. ; Picard, Michael H. ; Byrd, Benjamin F. ; Segar, Douglas S. ; Jacobson, Stuart A. ; Sahn, David J. ; Demaria, Anthony N. / 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. In: Journal of the American College of Cardiology. 1998 ; Vol. 32, No. 1. pp. 230-236.
@article{63d7a51a00414745a3c65bd5dc44edd2,
title = "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",
abstract = "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.",
author = "Grayburn, {Paul A.} and Weiss, {James L} and Hack, {Terrence C.} and Elizabeth Klodas and Raichlen, {Joel S.} and Vannan, {Manni A.} and Klein, {Allan L.} and Kitzman, {Dalane W.} and Chrysant, {Steven G.} and Cohen, {Jerald L.} and David Abrahamson and Elyse Foster and Perez, {Julio E.} and Aurigemma, {Gerard P.} and Panza, {Julio A.} and Picard, {Michael H.} and Byrd, {Benjamin F.} and Segar, {Douglas S.} and Jacobson, {Stuart A.} and Sahn, {David J.} and Demaria, {Anthony N.}",
year = "1998",
month = "7",
doi = "10.1016/S0735-1097(98)00219-8",
language = "English (US)",
volume = "32",
pages = "230--236",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "1",

}

TY - JOUR

T1 - 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

AU - Grayburn, Paul A.

AU - Weiss, James L

AU - Hack, Terrence C.

AU - Klodas, Elizabeth

AU - Raichlen, Joel S.

AU - Vannan, Manni A.

AU - Klein, Allan L.

AU - Kitzman, Dalane W.

AU - Chrysant, Steven G.

AU - Cohen, Jerald L.

AU - Abrahamson, David

AU - Foster, Elyse

AU - Perez, Julio E.

AU - Aurigemma, Gerard P.

AU - Panza, Julio A.

AU - Picard, Michael H.

AU - Byrd, Benjamin F.

AU - Segar, Douglas S.

AU - Jacobson, Stuart A.

AU - Sahn, David J.

AU - Demaria, Anthony N.

PY - 1998/7

Y1 - 1998/7

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0032127834&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0032127834&partnerID=8YFLogxK

U2 - 10.1016/S0735-1097(98)00219-8

DO - 10.1016/S0735-1097(98)00219-8

M3 - Article

C2 - 9669275

AN - SCOPUS:0032127834

VL - 32

SP - 230

EP - 236

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 1

ER -