Lumason® Infusion vs. Bolus Administrations
- Conditions
- Heart Diseases
- Interventions
- Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Registration Number
- NCT06400004
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 106
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bolus administration Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] Bolus administration of 2 mL undiluted Lumason® Continuous infusion Lumason Continuous infusion of 8 mL of diluted Lumason®
- Primary Outcome Measures
Name Time Method Adequate LV EBD Score 2-3 Hours Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
Adequate LV Opacification 2-3 Hours Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
- Secondary Outcome Measures
Name Time Method Clinically useful LVO 2-3 Hours To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration
Adverse events 24 Hours Compare adverse event rate after infusion vs. bolus administrations
Trial Locations
- Locations (3)
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States