Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141

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 (CE-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

NCT02522481

Run by

Bracco Diagnostics, Inc

People needed

175

Starts

2015-09-24

Expected to finish

2018-02-25

Last updated by the study team

2021-06-11

Who can join

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

You may qualify if…

• Provided written Informed Consent and was willing to comply with protocol requirements;
• Was at least 18 years of age;
• Had suspected or known CAD and was scheduled to undergo 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. Excluded 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

• Sarver Heart Center, University of Arizona — Tucson, Arizona, United States
• University of California San Diego — La Jolla, California, United States
• Interventional Cardiology Medical Group, Inc. — West Hills, California, United States
• Cardiology Physicians, PA — Newark, Delaware, United States
• Community Heart and Vascular Community Hospital East — Indianapolis, Indiana, United States
• St. Luke's Mid-America Heart Institute — Kansas City, Missouri, United States
• North Kansas City Hospital — North Kansas City, Missouri, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• The Institute for Clinical Research Holy Name Medical Center — Teaneck, New Jersey, United States
• Mount Sinai Medical Center — New York, New York, United States
• Mazankowski Alberta Heart Institute, University of Alberta Hospital — Edmonton, Alberta, Canada
• Medizinische Klinik m.S. Kardiologie und Angiologie, Charité Universitätsmedizin Berlin — Berlin, Germany
• Klinikum Lünen, St. Marien-Hospital GmbH — Lünen, Germany
• Universitätsmedizin Mainz — Mainz, Germany
• Kardiologie Klinik Dr. Müller GmbH, Peter Osypka Heart Center — Munich, Germany
• Azienda Ospedaliera Universitaria Parma — Parma, Italy
• Azienda Policlinico Umberto I Università degli Studi di Roma La Sapienza — Rome, Italy

Full record on ClinicalTrials.gov

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