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Kansas City, Missouri 64111


Purpose:

The purpose of this study is 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 are scheduled for coronary angiography.


Study summary:

The study is 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 of exclusion of the CAD. The study population consists of adult subjects referred for pharmacological stress echocardiography and with suboptimal image quality during unenhanced ultrasound imaging at rest who have known or suspected CAD. Subjects to be enrolled in the study are representative of subjects who could benefit most from CEUS stress echocardiography.


Criteria:

Inclusion Criteria: - Provides written Informed Consent and is willing to comply with protocol requirements; - Is at least 18 years of age; - Has suspected or known CAD and is scheduled to undergo coronary angiography within 6 months after the LUMASON DSE. - 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: - 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; - Has any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON); - Has any known hypersensitivity to dobutamine; - Has an ongoing or recent (within the last 30 days) acute myocardial infarction; - Has known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON); - Has electrolyte (especially potassium and magnesium) abnormalities; - Has 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; - Has uncontrolled cardiac arrhythmias; - Has significant disturbance in conduction; - Has hypertrophic subaortic stenosis; - Has 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; - Has been treated with any other contrast agent either intravascularly or orally within 48 hours of the first LUMASON administration; - 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: - Glaucoma; - Pyloric stenosis; - Prostatic hypertrophy.


NCT ID:

NCT02522481


Primary Contact:

Study Director
Melda Dolan, MD
Bracco Diagnostics, Inc


Backup Contact:

N/A


Location Contact:

Kansas City, Missouri 64111
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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