Expired Study
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Teaneck, New Jersey 07666


Purpose:

This is an intra-subject crossover comparative safety study to evaluate the effect of IV bolus injection of SonoVue on pulmonary hemodynamics. Subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. Each subject will receive two injections of SonoVue and one dose of placebo during right heart catheterization. The purpose is to provide direct evidence on the presence or absence of pulmonary hemodynamic effect following IV administration of SonoVue versus any effects following IV administration of the same volume of placebo.


Criteria:

Inclusion Criteria: - Provides written informed consent male or female at least 18 years of age scheduled to undergo right heart catheterization for clinical reasons Exclusion Criteria: - Pregnant or lactating females - Significant arrhythmia or non-sinus rhythm that may affect the ability to assess pulmonary hemodynamics - Known allergy to one of the ingredients in the investigational product or to any other contrast agents included ultrasound contrast agents - Previously entered into the study or received an investigational compound within 30 days before admission into the study - Unstable pulmonary and/or systemic hemodynamic condition that would affect the ability to evaluate the pharmacological or hemodynamic effect


NCT ID:

NCT01306292


Primary Contact:

Study Director
Maria Luigia Storto, MD
Bracco Diagnostics, Inc


Backup Contact:

N/A


Location Contact:

Teaneck, New Jersey 07666
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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