RecruitingHeart Diseases
Lumason® Infusion vs. Bolus Administrations
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Bracco Diagnostics, Inc
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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;
Where it's recruiting
Source: ClinicalTrials.gov · NCT06400004 · last updated 2026-03-05