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

ArmDescriptionAssigned Intervention
Active Comparator
Bolus administration 		Bolus administration of 2 mL undiluted Lumason®
  • Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
    Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds
    Other names:
    • Bolus Administration
Experimental
Continuous infusion 		Continuous infusion of 8 mL of diluted Lumason®
  • Drug: Lumason
    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
    Other names:
    • Infusion Administration

Recruiting Locations

Interventional Cardiology Medical Group
West Hills, California 91307
Contact:
Michael Fam, MD
818-743-0666
mfam@elegantrd.com

Piedmont Heart Institute
Atlanta, Georgia 30309
Contact:
Suzanne Corley
404-605-3118
suzanne.corley@piedmont.org

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Constance Angell-James, MPH
cangellj@bidmc.harvard.edu

Vital Heart and Vein
Humble, Texas 77338
Contact:
Ovee Muhebb
281-572-0109
s.muhebb@vitalheartandvein.com

More Details

Status
Recruiting
Sponsor
Bracco Diagnostics, Inc

Study Contact

Rushil Sankpal
609-514-2267
rushil.sankpal@diag.bracco.com

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.