Suspected or known Coronary Artery Disease MedDRA version: 18.0 Level: HLGT Classification code 10011082 Term: Coronary artery disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: SonoVue
Product Name: SonoVue
Product Code: BR1
Pharmaceutical Form: Powder and solvent for dispersion for injection
INN or Proposed INN: Sulfur Hexafluoride
CAS Number: SUB15925MIG
Concen
Sponsors
Bracco Imaging S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SonoVue-enhanced dobutamine stress echocardiography (DSE) in subjects with suspected or known CAD having suboptimal left ventricular (LV) endocardial border delineation (EBD) at unenhanced echocardiography in terms of: a) Sensitivity and specificity for the detection or exclusion of CAD in unenhanced versus SonoVue-enhanced DSE using coronary angiography or clinical follow-up as the truth standard; b) Critical shift from suboptimal (=2 adjacent segments inadequate on any apical view) at unenhanced dobutamine stress echocardiography (UE-DSE) to adequate images (reduction of suboptimal adjacent segments) for LV EBD at contrast-enhanced dobutamine stress echocardiography (CE-DSE). ;Secondary Objective: To further evaluate the following: a) Change from peak stress non-contrast ultrasound (Unenhanced-Dobutamine Stress Echocardiography) versus peak stress contrastenhanced ultrasound (Contrast Enhanced-Dobutamine Stress Echocardiography) in total Left Ventricle Endocardial Border Delineation score. b) To obtain safety data in subjects undergoing Dobutamine Stress Echocardiography with SonoVue.;Primary end point(s): Primary Objective(s): • To assess the efficacy of SonoVue-enhanced dobutamine stress echocardiography (DSE) in subjects with suspected or known coronary artery disease (CAD) having suboptimal left ventricular (LV) endocardial border delineation (EBD) at unenhanced echocardiography in terms of: 1) Sensitivity and specificity for the detection or exclusion of CAD in unenhanced versus SonoVue-enhanced DSE using coronary angiography or clinical follow-up as the truth standard; 2) Critical shift from suboptimal (=2 adjacent segments inadequate on any apical view) at unenhanced dobutamine stress echocardiography (UE-DSE) to adequate images (reduction of suboptimal adjacent segments) for LV EBD at contrast-enhanced dobutamine stress echocardiography (CE-DSE).;Timepoint(s) of evaluation of this end point: At the end of the bl | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Objective(s) 1) Change from peak stress non-contrast ultrasound (UE-DSE) versus peak stress contrast-enhanced ultrasound (CE-DSE) in total LV EBD score. 2) To obtain safety data in subjects undergoing DSE with SonoVue.;Timepoint(s) of evaluation of this end point: Change in total LV EBD scores at peak stress from UE-DSE to CE-DSE. | — |
Countries
Belgium, Canada, Netherlands, United Kingdom, United States
Contacts
Public ContactNadine Lambrecht
Ecron Acunova GmbH
Outcome results
None listed