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

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 SonoVue 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

1. A pregnant or lactating female. Exclude the possibility of pregnancy:
? a) by testing on site at the institution (serum or urine ßHCG) within 24 hours
priorto the start of SonoVue administration(s),
? b) by surgical history (e.g., tubal ligation or hysterectomy),
? c) post menopausal with a minimum 1 year without menses;
2. Has any known hypersensitivity to 1 or more ingredients of SonoVue (sulfur
hexafluoride or to any components of SonoVue);
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 SonoVue);
6. Has electrolyte (especially potassium and magnesium) abnormalities;
7. Has unstable pulmonary and/or systemic hemodynamic conditions e.g.:
? a) decompensated or inadequately controlled congestive heart failure (NYHA Class
IV);
? b) hypovolemia;
? c) uncontrolled hypertension, i.e. resting systolic blood pressure >200 mmHg or
diastolic blood pressure >110 mmHg;
? d) unstable angina;
? e) acute coronary syndrome;
? f) aortic dissection;
? g) acute pericarditis,
? h) myocarditis, or endocarditis;
? i) stenosis of the main left coronary artery;
j)hemodynamically significant outflow obstruction of the left ventricle, including
hypertrophic obstructive cardiomyopathy;
? k) hemodynamically significant cardiac valvular defect;
? l) acute pulmonary embolism;
8. Has uncontrolled cardiac arrhythmias;
9. Has significant disturbance in conduction;
10. Has hypertrophic subaortic stenosis;
11. Has an acute illness (e.g., infections, hyperthyroidism, or severe anemia);
12. Was previously entered into this study or received an investigational compound
within 30 days before admission into this study;
13. Has been treated with any other contrast agent either intravascularly or orally
within 48 hours of the first SonoVue administration;
14. 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.

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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