CaRES (Contrast Echocardiography Registry for Safety Surveillance)

A prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice

Robert J. Weiss, Masood Ahmad, Flordeliza Villanueva, Stephen Schmitz, Gajanan Bhat, Mark G. Hibberd, Michael L. Main

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Background: Definity (perflutren lipid microsphere) is an ultrasound contrast agent approved for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. This prospective, open-label, nonrandomized, multicenter, phase 4 surveillance registry study was conducted at 15 clinical sites in the United States and was designed to assess the risk for adverse cardiopulmonary events occurring during or within the initial 30 min after Definity administration in routine clinical practice. Methods: Patients with suboptimal baseline images were consecutively approached regarding study participation. Safety monitoring including vital sign measurements, continuous electrocardiographic monitoring, and continuous oxygen saturation was initiated at baseline before Definity administration and then at regular intervals for 30 min after Definity injection. Patients were assessed for adverse events at 30 min after Definity administration and then contacted by telephone at 24 ± 4 hours to record any subsequent adverse events. Results: A total of 1,060 patients were enrolled at 15 clinical sites. Of these, 1,053 (99.3%) received at least one dose of Definity and completed the study. No deaths, serious adverse events, or other significant adverse events occurred during this study. The overall adverse event rate was 10.8% (4.5% in patients undergoing rest echocardiography, 13% in patients undergoing rest and exercise stress echocardiography, and 27.7% in patients undergoing rest and pharmacologic stress echocardiography). The overall drug-related adverse event rate (patients with at least one adverse event reported by the principal investigator as related to Definity) was only 3.5%, and most of these (110 of 114 [96.5%]) were reported by the investigator as mild or moderate in intensity. Conclusions: Definity is well tolerated in routine clinical practice in patients with a high prevalence of cardiopulmonary disease.

Original languageEnglish (US)
Pages (from-to)790-795
Number of pages6
JournalJournal of the American Society of Echocardiography
Volume25
Issue number7
DOIs
StatePublished - Jul 2012

Fingerprint

Contrast Media
Multicenter Studies
Registries
Echocardiography
Prospective Studies
Safety
Stress Echocardiography
perflutren
Research Personnel
Definity
Vital Signs
Drug-Related Side Effects and Adverse Reactions
Microspheres
Telephone
Exercise
Oxygen
Lipids
Injections

Keywords

  • Contrast echocardiography
  • Safety
  • Ultrasound contrast agents

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

CaRES (Contrast Echocardiography Registry for Safety Surveillance) : A prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. / Weiss, Robert J.; Ahmad, Masood; Villanueva, Flordeliza; Schmitz, Stephen; Bhat, Gajanan; Hibberd, Mark G.; Main, Michael L.

In: Journal of the American Society of Echocardiography, Vol. 25, No. 7, 07.2012, p. 790-795.

Research output: Contribution to journalArticle

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abstract = "Background: Definity (perflutren lipid microsphere) is an ultrasound contrast agent approved for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. This prospective, open-label, nonrandomized, multicenter, phase 4 surveillance registry study was conducted at 15 clinical sites in the United States and was designed to assess the risk for adverse cardiopulmonary events occurring during or within the initial 30 min after Definity administration in routine clinical practice. Methods: Patients with suboptimal baseline images were consecutively approached regarding study participation. Safety monitoring including vital sign measurements, continuous electrocardiographic monitoring, and continuous oxygen saturation was initiated at baseline before Definity administration and then at regular intervals for 30 min after Definity injection. Patients were assessed for adverse events at 30 min after Definity administration and then contacted by telephone at 24 ± 4 hours to record any subsequent adverse events. Results: A total of 1,060 patients were enrolled at 15 clinical sites. Of these, 1,053 (99.3{\%}) received at least one dose of Definity and completed the study. No deaths, serious adverse events, or other significant adverse events occurred during this study. The overall adverse event rate was 10.8{\%} (4.5{\%} in patients undergoing rest echocardiography, 13{\%} in patients undergoing rest and exercise stress echocardiography, and 27.7{\%} in patients undergoing rest and pharmacologic stress echocardiography). The overall drug-related adverse event rate (patients with at least one adverse event reported by the principal investigator as related to Definity) was only 3.5{\%}, and most of these (110 of 114 [96.5{\%}]) were reported by the investigator as mild or moderate in intensity. Conclusions: Definity is well tolerated in routine clinical practice in patients with a high prevalence of cardiopulmonary disease.",
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AU - Villanueva, Flordeliza

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AU - Hibberd, Mark G.

AU - Main, Michael L.

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AB - Background: Definity (perflutren lipid microsphere) is an ultrasound contrast agent approved for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. This prospective, open-label, nonrandomized, multicenter, phase 4 surveillance registry study was conducted at 15 clinical sites in the United States and was designed to assess the risk for adverse cardiopulmonary events occurring during or within the initial 30 min after Definity administration in routine clinical practice. Methods: Patients with suboptimal baseline images were consecutively approached regarding study participation. Safety monitoring including vital sign measurements, continuous electrocardiographic monitoring, and continuous oxygen saturation was initiated at baseline before Definity administration and then at regular intervals for 30 min after Definity injection. Patients were assessed for adverse events at 30 min after Definity administration and then contacted by telephone at 24 ± 4 hours to record any subsequent adverse events. Results: A total of 1,060 patients were enrolled at 15 clinical sites. Of these, 1,053 (99.3%) received at least one dose of Definity and completed the study. No deaths, serious adverse events, or other significant adverse events occurred during this study. The overall adverse event rate was 10.8% (4.5% in patients undergoing rest echocardiography, 13% in patients undergoing rest and exercise stress echocardiography, and 27.7% in patients undergoing rest and pharmacologic stress echocardiography). The overall drug-related adverse event rate (patients with at least one adverse event reported by the principal investigator as related to Definity) was only 3.5%, and most of these (110 of 114 [96.5%]) were reported by the investigator as mild or moderate in intensity. Conclusions: Definity is well tolerated in routine clinical practice in patients with a high prevalence of cardiopulmonary disease.

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