Ongoing Trials
CaRES*
Contrast Echocardiography REgistry for Safety Surveillance
Objective
The objective of this study is to provide safety information about the use of contrast in routine clinical practice to the echo community.
Background
The FDA requested all manufacturers of perflutren ultrasound contrast agents currently available in the USA revise their Prescribing Information following their review of post-market safety reports of serious cardiopulmonary reactions. After discussions with the FDA, Lantheus Medical Imaging has initiated a registry study to further explore the safety profile of DEFINITY® in clinical practice.
Methods
CaRES (Contrast Echocardiolgraphy REgistry for Safety Surveillance) is an open-label, non-randomized, multi-center Phase 4 observational registry which will include at least 1,600 patients, and be conducted in at least 10 clinical sites in the United States.
The registry is gathering data on:
- Patient characteristics and demographics
- Indication for the contrast study
- Results of the safety monitoring of patients during and after DEFINITY® administration
- Nature and frequency of any adverse events that may occur
Conclusion
The conclusion of this study will provide the echo community with additional information about the safety of ultrasound contrast agents in patients with suboptimal echoes.
For more information call (978)671-8056
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INDICATIONS
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established.
CONTRAINDICATIONS
Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
- Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS).
- In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS).
- Always have resuscitation equipment and trained personnel readily available.
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In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration (see ADVERSE REACTIONS). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
Please See Full Prescribing Information and Letter to Healthcare Providers.
