Clinical trial NCT02522481: Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Lumason
Dobutamine stress echo
stress echo
coronary artery disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The study was designed to assess the safety and efficacy of Lumason at improving the visualization of the LV EBD during pharmacologic stress echocardiography examinations and for detection or exclusion of the coronary artery disease (CAD). The study population consisted of adult subjects referred for pharmacological stress echocardiography and with suboptimal image quality during unenhanced ultrasound imaging at rest who had known or suspected CAD. Subjects enrolled in the study represented subjects who could benefit most from contrast-enhanced ultrasound (CEUS) stress echocardiography.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Had any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations;

In addition, due to the use of Atropine in subjects who had not reached targeted heart rate with peak dobutamine infusion, subjects with the following were excluded:

* Glaucoma;
* Pyloric stenosis;
* Prostatic hypertrophy.

Primary outcomes:
measure: Sensitivity and Specificity for Detection or Exclusion of Coronary Artery Disease (CAD)
timeFrame: Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography were performed
measure: Reader-Specific Percentages of Participants Identified as Having a Critical Shift From Suboptimal to Optimal Echocardiographic Images
timeFrame: Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed
Secondary outcomes:
measure: Change in Total LV EBD
timeFrame: Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed
measure: Number of Participants With Adverse Events
timeFrame: up to 72 hours post dose
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Sarver Heart Center, University of Arizona
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: West Hills
country: United States
facility: Interventional Cardiology Medical Group, Inc.
state: California
city: Newark
country: United States
facility: Cardiology Physicians, PA
state: Delaware
city: Indianapolis
country: United States
facility: Community Heart and Vascular Community Hospital East
state: Indiana
city: Kansas City
country: United States
facility: St. Luke's Mid-America Heart Institute
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: The Institute for Clinical Research Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute, University of Alberta Hospital
state: Alberta
city: Berlin
country: Germany
facility: Medizinische Klinik m.S. Kardiologie und Angiologie, Charité Universitätsmedizin Berlin
city: Lünen
country: Germany
facility: Klinikum Lünen, St. Marien-Hospital GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Munich
country: Germany
facility: Kardiologie Klinik Dr. Müller GmbH, Peter Osypka Heart Center
city: Parma
country: Italy
facility: Azienda Ospedaliera Universitaria Parma
city: Rome
country: Italy
facility: Azienda Policlinico Umberto I Università degli Studi di Roma La Sapienza
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Melda Dolan, MD
role: STUDY_DIRECTOR
References: