Lumason® Infusion vs. Bolus Administrations

Recruiting now · Phase 3

Conditions studied: Heart Diseases

In brief

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).

Key facts

Study ID

NCT06400004

Run by

Bracco Diagnostics, Inc

People needed

106

Starts

2024-07-10

Expected to finish

2026-12-31

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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.

Where it is running

• Interventional Cardiology Medical Group — West Hills, California, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Vital Heart and Vein — Humble, Texas, United States (enrolling)
• Oregon Health and Sciences University — Portland, Oregon, United States
• University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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