EUCTR2015-001962-25-GB
Active, not recruiting
Phase 1
A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress Echocardiography with Dobutamine for the Diagnosis of Coronary Artery Disease - BR1-142 Lumason/SonoVue in Stress Echocardiography
ConditionsSuspected or known Coronary Artery DiseaseMedDRA version: 18.0Level: HLGTClassification code 10011082Term: Coronary artery disordersSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsSonoVue
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Suspected or known Coronary Artery Disease
- Sponsor
- Bracco Imaging S.p.A.
- Enrollment
- 175
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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