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

Inclusion criteria

• 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

Exclusion criteria

• 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