Lumason® Infusion vs. Bolus Administrations
Purpose
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).
Condition
- Heart Diseases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Bolus administration |
Bolus administration of 2 mL undiluted Lumason® |
|
|
Experimental Continuous infusion |
Continuous infusion of 8 mL of diluted Lumason® |
|
Recruiting Locations
Interventional Cardiology Medical Group
West Hills, California 91307
West Hills, California 91307
Piedmont Heart Institute
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Vital Heart and Vein
Humble, Texas 77338
Humble, Texas 77338
More Details
- Status
- Recruiting
- Sponsor
- Bracco Diagnostics, Inc
Detailed Description
This is 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). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.