Phase
Condition
N/ATreatment
NH002 (Perflutren Lipid Microspheres) Injectable Suspension
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theventricular 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
Exclusion Criteria:
Subjects will be excluded from the study if one or more of the following exclusion criteria are applicable:
Any evidence of other severe or unstable cardiopulmonary and/or systemic hemodynamicconditions deemed unsuitable for the study by the investigator(s) prior to NH002dose 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 YorkHeart Association Class IV).
atrial fibrillation or current uncontrolled cardiac arrhythmias causingsymptoms or hemodynamic compromise.
uncontrolled hypertension (i.e., resting systolic blood pressure >200 mmHg ordiastolic blood pressure >110 mmHg or arterial hypotension [defined as systolicblood 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 polyethylene glycol, prior reactions tocommon polyethylene glycol-containing products such as colonoscopy bowelpreparations, 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 priorto NH002 dose administration
Pregnant or lactating female. Exclude the possibility of pregnancy:
testing on-site at the institution (serum or urine β-human chorionicgonadotropin) within 24 hours prior to the start of NH002 dose administration,and
history of using an adequate and medically approved method of contraception toavoid pregnancy for at least 1 month prior to NH002 dose administration andwilling 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 theinvestigator, to interfere with compliance to protocol treatment/research
Study Design
Connect with a study center
Keelung Chang Gung Memorial Hospital & Lovers Lake Branch
Keelung, 204201
TaiwanSite Not Available
Keelung Chang Gung Memorial Hospital & Lovers Lake Branch
Keelung 1678228, 204201
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 404327
TaiwanSite Not Available
China Medical University Hospital
Taichung 1668399, 404327
TaiwanActive - Recruiting
Cathay General Hospital
Taipei, 106438
TaiwanSite Not Available
MacKay Memorial Hospital
Taipei, 104217
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Cathay General Hospital
Taipei 1668341, 106438
TaiwanActive - Recruiting
MacKay Memorial Hospital
Taipei 1668341, 104217
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei 1668341, 11217
TaiwanActive - Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Zhubei, 302058
TaiwanSite Not Available
National Taiwan University Hospital Hsin-Chu Branch
Zhubei 1677112, 302058
TaiwanActive - Recruiting

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