A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 6
- 主要终点
- Adequate LV EBD Score
研究概览
简要总结
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
详细描述
This is a phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 18-years old;
- •Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
- •Provide their written informed consent and are willing to comply with protocol requirements.
排除标准
- •Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);
- •Patient has uncontrolled angina (i.e., uncontrolled on medication);
- •Patient had a recent myocardial infarction (within the last 3 days and not stabilized);
- •Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
- •Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;
- •Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;
- •Has any known allergy to one or more of the ingredients of the investigational product;
- •Is pregnant or lactating. Exclude the possibility of pregnancy by: testing on site (serum or urine βHCG) prior to the start of investigational product administration; surgical history (e.g., tubal ligation or hysterectomy); post-menopausal with a minimum 1 year without menses;
- •Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;
- •Is determined by the Investigator that the patient is clinically unsuitable for the study.
研究组 & 干预措施
Bolus administration
Bolus administration of 2 mL undiluted Lumason®
干预措施: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (Drug)
Continuous infusion
Continuous infusion of 8 mL of diluted Lumason®
干预措施: Lumason (Drug)
结局指标
主要结局
Adequate LV EBD Score
时间窗: 2-3 Hours
Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
Adequate LV Opacification
时间窗: 2-3 Hours
Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
次要结局
- Clinically useful LVO(2-3 Hours)
- Adverse events(24 Hours)