A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent Administrated Via Intravenous Bolus Injection and Infusion for Subjects Undergoing Cardiac Echocardiography
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Left Ventricular Endocardial Border Delineation (LVEBD)
研究概览
简要总结
This is a phase III, prospective, multicenter, open-label, crossover study of the safety and efficacy of NH002-enhanced echocardiography in adult subjects with suboptimal images on non-contrast 2D transthoracic echocardiography with harmonic imaging within 30 days ahead of NH002 administration. The efficacy for two different modes of administration (i.e., IV bolus injection and infusion) will be evaluated independently.
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
- 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
- •18 years of age or older
- •Ability to understand and the willingness to provide written informed consent
- •Having or suspected of having cardiac disease
- •Undergone a transthoracic echo within 30 days prior to NH002 dose administration, resulting in suboptimal LVEBD, as defined by 2 or more segments of 6 segments of the ventricular border that cannot be visualized reliably in any of the standard apical 4-, 2-, and 3-chamber views during the resting non-contrast ultrasound examination
排除标准
- •Any evidence of other severe or unstable cardiopulmonary and/or systemic hemodynamic conditions deemed unsuitable for the study by the investigator(s) prior to NH002 dose administration, including, but not limited to:
- •ongoing or recent acute coronary syndrome within 6 months
- •uncontrolled serious ventricular arrhythmias
- •decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV)
- •atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
- •uncontrolled hypertension (i.e., resting systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg, or arterial hypotension [defined as systolic blood pressure ≤ 90 mmHg])
- •acute aortic dissection
- •Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, Definity, or other echocardiographic contrast agents
- •Known or suspected hypersensitivity to PEG, prior reactions to common PEG-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)
- •Received an investigational compound within 30 days before enrolling in the study
- •Received any contrast agent either intravascularly or orally within 48 hours prior to NH002 dose administration
- •Pregnant or lactating female. Exclude the possibility of pregnancy:
- •testing on-site at the institution (serum or urine β-human chorionic gonadotropin) within 7 days prior to the start of NH002 dose administration, and
- •history of using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to NH002 dose administration and willing to continue using the same method for the duration of the study, or
- •surgical history (e.g., tubal ligation or hysterectomy), or
- •postmenopausal with a minimum of 1 year without menses.
- •Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance with protocol treatment/research
结局指标
主要结局
Left Ventricular Endocardial Border Delineation (LVEBD)
时间窗: Image data obtained pre-injection and within 15 minutes post-injection
The first primary efficacy endpoint will be the change from baseline (prior to each dose of NH002 administration) in total LVEBD scores (UEUS vs CEUS) defined using a 16-segment model derived from the standard 17-segment model, as assessed through blinded central reading. The LV endocardium of the standard apical 4-, 2-, and 3-chamber views is divided into 6 segments, with 2 basal, mid-, and apical segments in each view, of which 2 segments are shared in the standard apical 4- and 3-chamber views (i.e., a total of 16 segments in the 3 views). The 17th segment at the apex will not be scored since it does not connect to any part of the LV endocardial border. For each segment, LVEBD is graded as follows: 0 = inadequate border (border not visible); 1 = sufficient (border barely visible); 2 = good (border clearly visible). A total delineation score (0 to 32) is obtained by adding the scores from a total of the 16 segments in the 3 views.
Left Ventricular Opacification (LVO)
时间窗: Image data obtained pre-injection and within 15 minutes post-injection
The co-primary endpoint will be the proportion of subjects with adequate LVO defined by an LVO grade of +2 (moderate) or +3 (complete), as assessed through blinded central reading.
次要结局
- The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography(Image data obtained pre-injection and within 15 minutes post-injection)
- Standard 12-lead ECGs(From pre-injection (before the first dose) to 24 hours (after the end of second dose))
- Blood Pressure (BP)(From pre-injection (before the first dose) to 24 hours (after the end of second dose))
- Heart Rate (HR)(From pre-injection (before the first dose) to 24 hours (after the end of second dose))
- SpO2(From pre-injection (before the first dose) to 24 hours (after the end of second dose))
- Physical Examination (PE)(From pre-injection (before the first dose) to 24 hours (after the end of second dose))
- Adverse Events (AEs)(From pre-injection (before the first dose) to 24 hours (after the end of second dose))