Lumason® Infusion vs. Bolus Administrations
A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
Bracco Diagnostics, Inc
106 participants
Jul 10, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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 severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
- Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;
- Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;
- Has any known allergy to one or more of the ingredients of the investigational product;
- Is pregnant or lactating. Exclude the possibility of pregnancy by: testing on site (serum or urine βHCG) prior to the start of investigational product administration; surgical history (e.g., tubal ligation or hysterectomy); post-menopausal with a minimum 1 year without menses;
- Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;
- Is determined by the Investigator that the patient is clinically unsuitable for the study.
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Interventions
Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds
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)
View Full Details on ClinicalTrials.gov
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NCT06400004