NCT03571672已完成3 期
A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY®-Enhanced 2D-Echo and Magnetic Resonance Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 9
- 主要终点
- Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader
研究概览
简要总结
This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Men and women ≥ 18 years of age in sinus rhythm
- •Able to communicate effectively with trial personnel
- •Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
- •Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -
排除标准
- •Female subjects who are pregnant or lactating. All women of child bearing potential [WOCBP] must have a negative urine pregnancy test at screening regardless of contraceptive use history.
- •Women of child-bearing potential are excluded unless they:
- •are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
- •have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
- •have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
- •Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
- •Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).
- •Unstable cardiovascular status defined as:
- •myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
- •transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
- •symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
- •clinically significant congenital heart defects
- •current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
- •acute pulmonary embolus or pulmonary infarction
- •acute myocarditis or pericarditis
- •acute aortic dissection
- •atrial fibrillation
- •any major surgery within 4 weeks prior to screening
- •known contraindications to undergoing CMR or claustrophobia
- •participation in any investigational drug, device, or placebo study within 30 days prior to screening
- •known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
- •prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -
研究组 & 干预措施
DEFINITY
Experimental
Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound
干预措施: DEFINITY (Drug)
结局指标
主要结局
Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader
时间窗: Up to 30 days between day of echocardiograms and CMR imaging
Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using Definity contrast-enhanced over unenhanced echocardiography by comparing LVEF Percentage Differences from CMR measured by 3 independent blinded image readers.
次要结局
- Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms(Up to 30 days between day of echocardiograms and CMR imaging)
- Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers(Up to 30 days between day of echocardiograms and CMR imaging)
- Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms(Up to 30 days between day of echocardiograms and CMR imaging)
- Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms(Up to 30 days between day of echocardiograms and CMR imaging)
- Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers(Up to 30 days between day of echocardiograms and CMR imaging)
研究者
研究点 (9)
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