Phase
Condition
Cardiac Disease
Treatment
NH002 (Perflutren Lipid Microspheres) Injectable Suspension
Echocardiogram
Clinical Study ID
Ages > 20 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 forcongenital heart disease
Negative pregnancy test within 24 hours of the procedure if subject is a woman ofchildbearing potential
Exclusion
Exclusion Criteria:
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 toprolongation of the QT interval (QT corrected by Fridericia's formula >450 msec inmales and >470 msec in females)
Clinically significant abnormality in renal and liver function tests (alanineaminotransferase/aspartate aminotransferase >2 × upper limit of normal [ULN]; serumcreatinine > 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 beforeNH002 administration
Pregnant or lactating female (conception during the study should be avoided)
Serious medical or psychiatric illness/condition likely, in the judgment of theinvestigator, to interfere with compliance to protocol treatment/research
Clinically unstable cardiopulmonary conditions considered not suitable forparticipation in the trial, in the judgment of the investigator
Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg ordiastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolicblood pressure ≤ 90 mmHg)
Study Design
Connect with a study center
Taipei Mackay Memorial Hospital
Taipei, 10449
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Taipei Mackay Memorial Hospital
Taipei 1668341, 10449
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341, 11217
TaiwanSite Not Available

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