Actively Recruiting
Lumason® Infusion vs. Bolus Administrations
Led by Bracco Diagnostics, Inc · Updated on 2026-03-05
106
Participants Needed
6
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Lumason® Infusion vs. Bolus Administrations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 b2HCG) 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Interventional Cardiology Medical Group
West Hills, California, United States, 91307
Actively Recruiting
2
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Not Yet Recruiting
5
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Withdrawn
6
Vital Heart and Vein
Humble, Texas, United States, 77338
Actively Recruiting
Research Team
R
Rushil Sankpal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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