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

Enroll a subject in this study if the subject meets the following 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

Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:
• Is a pregnant or lactating female. Exclude the possibility of pregnancy:
1) by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the start of SonoVue administration(s),
2) by surgical history (e.g., tubal ligation or hysterectomy),
3) 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.

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.

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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