Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-142

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT02552238

Run by

Bracco Diagnostics, Inc

People needed

174

Starts

2015-10-12

Expected to finish

2018-02-25

Last updated by the study team

2021-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Was a pregnant or lactating female. Exclude the possibility of pregnancy: by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of LUMASON administration(s), by surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses;
• Had any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON);
• Had any known hypersensitivity to dobutamine;
• Had an ongoing or recent (within the last 30 days) acute myocardial infarction;
• Had known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON);
• Had electrolyte (especially potassium and magnesium) abnormalities;
• Had unstable pulmonary and/or systemic hemodynamic conditions e.g.:
• decompensated or inadequately controlled congestive heart failure (NYHA Class IV);
• hypovolemia;
• uncontrolled hypertension, i.e. resting systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg;
• unstable angina;
• acute coronary syndrome;
• aortic dissection;
• acute pericarditis,
• myocarditis, or endocarditis;
• stenosis of the main left coronary artery;
• hemodynamically significant outflow obstruction of the left ventricle, including hypertrophic obstructive cardiomyopathy;
• hemodynamically significant cardiac valvular defect;
• acute pulmonary embolism;
• Had uncontrolled cardiac arrhythmias;
• Had significant disturbance in conduction;
• Had hypertrophic subaortic stenosis;
• Had an acute illness (e.g., infections, hyperthyroidism, or severe anemia);
• Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
• Had been treated with any other contrast agent either intravascularly or orally within 48 hours of the first LUMASON administration;

Where it is running

• Coastal Multi-Specialty Research, Coastal Heart Medical Group — Santa Ana, California, United States
• Alfieri Cardiology — Wilmington, Delaware, United States
• Homestead Cardiac and Vein Center — Homestead, Florida, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• St. Louis University Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Duke University Medical Center Cardiac Diagnostic Unit — Durham, North Carolina, United States
• University of Texas Medical Branch at Galveston — Galveston, Texas, United States
• Cliniques Universitaires Saint-Luc Unité de Pathologie Cardio-Vasculaire / Cardiologie — Brussels, Belgium
• Antwerp University Hospital — Edegem, Belgium
• St. Michael's Hospital — Toronto, Ontario, Canada
• Northwick Park Hospital — Harrow, Middlesex, United Kingdom
• Hammersmith Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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