umason™/SonoVue® in Stress Echocardiography with Dobutamine for the Diagnosis of Coronary Artery Disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 175

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 SonoVue® 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

- Is a pregnant or lactating female. Exclude the possibility of pregnancy:
by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the start of SonoVue®
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 SonoVue® (sulfur hexafluoride or to any components of SonoVue®);
- 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 SonoVue®);
- 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 SonoVue® 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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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