LUMASON

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 - Raj Janardhanan, MD

Inclusion Criteria 

Enroll a subject in this study if the subject meets the following inclusion criteria: 

  1. Provides written Informed Consent and is willing to comply with protocol requirements; 
  2. Is at least 18 years of age; 
  3. Has suspected or known CAD and is scheduled to undergo coronary angiography within 6 months after the LUMASON DSE. 
  4. Has 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 

Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed: 

  1. Is 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; 
  2. Has any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON); 
  3. Has any known hypersensitivity to dobutamine; 
  4. Has an ongoing or recent (within the last 30 days) acute myocardial infarction; 
  5. Has known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON); 
  6. Has electrolyte (especially potassium and magnesium) abnormalities; 
  7. Has unstable pulmonary and/or systemic hemodynamic conditions e.g.: decompensated or inadequately controlled congestive heart failure (NYHA Class IV); hypovolemia; 
  8. 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; 
  9. Has uncontrolled cardiac arrhythmias; 
  10. Has significant disturbance in conduction; 
  11. Has hypertrophic subaortic stenosis; 
  12. Has an acute illness (e.g., infections, hyperthyroidism, or severe anemia); 
  13. Was previously entered into this study or received an investigational compound within 30 days before admission into this study; 
  14. Has been treated with any other contrast agent either intravascularly or orally within 48 hours of the first LUMASON administration; 
  15. Has 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 have not reached targeted heart rate with peak dobutamine infusion, subjects with the following will be excluded: 

  1. Glaucoma; 
  2. Pyloric stenosis; 
  3. Prostatic hypertrophy.

For more information, contact coordinators: Ashley Larsen, golmana@shc.arizona.edu and Alyssa Crone, acrone@shc.arizona.edu