Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Lumason
Intervention description: Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lumason; Dobutamine stress echo; stress echo; coronary artery disease

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.
    

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.