EUCTR2015-001713-28-DE进行中（未招募）1 期
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 - Lumason™/SonoVue® in Stress Echocardiography
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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