A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
Bracco Diagnostics, Inc
Summary
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Description
This is a phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Are at least 18-years old; * Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram; * Provide their written informed consent and are willing to comply with protocol requirements. Exclusion Criteria: * Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association); * Patient has uncontrolled angina (i.e., uncontrolled on medication); * Patient had a recent myocardial infarction (within the last 3 days and not stabilized); * Patient has…
Interventions
- DrugSulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds
- DrugLumason
Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min
Locations (6)
- Interventional Cardiology Medical GroupWest Hills, California
- Piedmont Heart InstituteAtlanta, Georgia
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Oregon Health and Sciences UniversityPortland, Oregon
- University of Texas Medical BranchGalveston, Texas
- Vital Heart and VeinHumble, Texas