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Lumason® Infusion vs. Bolus Administrations

RecruitingPhase 3Ages 18 Years - anyAllBracco Diagnostics, Inc
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
  • Lumason
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Where

6 sites
Interventional Cardiology Medical Group
West Hills, United States
Piedmont Heart Institute
Atlanta, United States
Beth Israel Deaconess Medical Center
Boston, United States
Oregon Health and Sciences University
Portland, United States
University of Texas Medical Branch
Galveston, United States
Vital Heart and Vein
Humble, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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