NOT_YET_RECRUITING
Lumason® Infusion vs. Bolus Administrations
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).
Conditions:
🦠 Heart Diseases
🗓️ Study Start (Actual) 30 April 2024
🗓️ Primary Completion (Estimated) 31 July 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 106
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Atlanta, Georgia, United States
📍 Boston, Massachusetts, United States
📍 Portland, Oregon, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 April 2024
  • First Submitted that Met QC Criteria 1 May 2024
  • First Posted 6 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 May 2024
  • Last Update Posted 6 May 2024
  • Last Verified April 2024