Clinical trial NCT02552238: Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-142
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: 2015-09-17
Enrollment: 174
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 (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 CEUS stress echocardiography.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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;
* 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 of Lumason Enhanced Dobutamine Stress Echo (DSE) 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: 72 hours post dose
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Coastal Multi-Specialty Research, Coastal Heart Medical Group
state: California
city: Wilmington
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Homestead
country: United States
facility: Homestead Cardiac and Vein Center
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Durham
country: United States
facility: Duke University Medical Center Cardiac Diagnostic Unit
state: North Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc Unité de Pathologie Cardio-Vasculaire / Cardiologie
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Melda Dolan, MD
role: STUDY_DIRECTOR
References: