A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason™/SonoVue® in Subjects Undergoing Pharmacologic Stress Echocardiography With Dobutamine for the Diagnosis of Coronary Artery Disease
Status: Completed
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Provided written Informed Consent and comply with protocol requirements;
• Was at least 18 years of age;
• Had suspected of having CAD and undergoing coronary angiography within 6 months after the LUMASON DSE.
• Had undergone a previous echocardiography prior to enrollment; resulting in suboptimal unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical view.
Locations
United States
California
Coastal Multi-Specialty Research, Coastal Heart Medical Group
Santa Ana
Delaware
Alfieri Cardiology
Wilmington
Florida
Homestead Cardiac and Vein Center
Homestead
Louisiana
Ochsner Clinic Foundation
New Orleans
Missouri
St. Louis University Hospital
Saint Louis
North Carolina
Duke University Medical Center Cardiac Diagnostic Unit
Durham
Nebraska
University of Nebraska Medical Center
Omaha
Texas
University of Texas Medical Branch at Galveston
Galveston
Other Locations
Belgium
Cliniques Universitaires Saint-Luc Unité de Pathologie Cardio-Vasculaire / Cardiologie
Bruxelles
Antwerp University Hospital
Edegem
Canada
St. Michael's Hospital
Toronto
United Kingdom
Northwick Park Hospital
Harrow
Hammersmith Hospital
London
Time Frame
Start Date: 2015-10-12
Completion Date: 2018-02-25
Participants
Target number of participants: 174
Treatments
Experimental: Lumason
Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection
Authors
Related Therapeutic Areas
Sponsors
Leads: Bracco Diagnostics, Inc