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Lumason® Infusion vs. Bolus Administrations
RecruitingPhase 3
A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 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.
About the 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).
What is being tested
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (drug)
- Lumason (drug)
Sponsor: Bracco Diagnostics, Inc · Participants: 106 · Started: Jul 10, 2024
Contact the study team
- Rushil Sankpal · Phone: 609-514-2267
Official record on ClinicalTrials.gov — NCT06400004
Locations in the U.S.
| California | Interventional Cardiology Medical Group, West Hills |
| Georgia | Piedmont Heart Institute, Atlanta |
| Massachusetts | Beth Israel Deaconess Medical Center, Boston |
| Oregon | Oregon Health and Sciences University, Portland (Not yet recruiting) |
| Texas | Vital Heart and Vein, Humble |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.