Heart Diseases
Conditions
Brief summary
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).
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.
Interventions
Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds
DRUGLumason
Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate LV EBD Score | 2-3 Hours | Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography. |
| Adequate LV Opacification | 2-3 Hours | Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically useful LVO | 2-3 Hours | To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration |
| Adverse events | 24 Hours | Compare adverse event rate after infusion vs. bolus administrations |
Countries
United States
Contacts
CONTACTRushil Sankpal
STUDY_DIRECTORJose Banchs, MD
Sr. Medical Director
Outcome results
None listed