A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Rate of Any Potential Adverse Allergic Reaction
研究概览
简要总结
NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The reviewer of echocardiograms in this trial is blinded to the treatment assignments and subject identifiers.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 20 years of age or older
- •Ability to understand and the willingness to provide written informed consent
- •Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
- •Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential
排除标准
- •Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)
- •Chronic obstructive pulmonary disease
- •Ejection fraction at screening or baseline <40%
- •Uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due to prolongation of the QT interval (QT corrected by Fridericia's formula >450 msec in males and >470 msec in females)
- •Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase >2 × upper limit of normal [ULN]; serum creatinine > 1.5 × ULN)
- •Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent
- •Received an investigational compound within 30 days before enrolling in the study
- •Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration
- •Pregnant or lactating female (conception during the study should be avoided)
- •Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research
- •Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator
- •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)
研究组 & 干预措施
Single arm
Subjects will be enrolled with sequential allocation to 1 of 3 cohorts with the following intravenous (IV) doses of NH002: 2.5 µl/kg, 5.0 µl/kg, or 10.0 µl/kg.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day
干预措施: NH002 (Perflutren Lipid Microspheres) Injectable Suspension (Drug)
Single arm
Subjects will be enrolled with sequential allocation to 1 of 3 cohorts with the following intravenous (IV) doses of NH002: 2.5 µl/kg, 5.0 µl/kg, or 10.0 µl/kg.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day
干预措施: Echocardiogram (Diagnostic Test)
结局指标
主要结局
Rate of Any Potential Adverse Allergic Reaction
时间窗: From pre-injection to 240 minutes post-injection
Monitor for any potential adverse allergic reaction
12-lead ECGs
时间窗: From pre-injection to 60 minutes post injection
Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal
Body Temperature
时间窗: From pre-injection to 120 minutes post injection
Monitor for any changes in body temperature (in Celsius degree)
Respiratory Rate
时间窗: From pre-injection to 120 minutes post injection
Monitor for any changes in respiratory rate (in breaths/min)
Blood Pressure
时间窗: From pre-injection to 120 minutes post injection
Monitor for any changes in blood pressure (in mmHg)
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
时间窗: From pre-injection to 240 minutes post-injection
Monitor for any changes in TT and aPTT
Cardiac Troponin I
时间窗: pre-injection and 240 minutes post-injection
Monitor for any changes in Cardiac troponin I
Heart Rate
时间窗: From pre-injection to 120 minutes post injection
Monitor for any changes in heart rate (in beats/min)
Oxygen Saturation by Pulse Oximetry (SpO2)
时间窗: From pre-injection to 120 minutes post-injection
Monitor for any changes in SpO2
Cardiac Troponin T
时间窗: pre-injection and 240 minutes post-injection
Monitor for any changes in Cardiac troponin T
次要结局
- Left Ventricular Opacification (LVO)(Image data obtained pre-injection and within 10 minutes post-injection)
- Left Ventricular Endocardial Border Delineation (LVEBD)(Image data obtained pre-injection and within 10 minutes post-injection)
- Duration of Clinically Useful Contrast(Image data obtained pre-injection and within 10 minutes post-injection)