Phase
Condition
N/ATreatment
Echocardiogram
MVT-100
Definity
Clinical Study ID
Ages > 19 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult subjects 19 years of age or older, male or female
Female subjects must no longer have child-bearing potential (>1-year post menopauseor surgically sterilized), or must
have a negative urine pregnancy test, and
be using and continue to use for 30 days after the study a medically effectivemethod of contraception
Adequate hematologic, renal and hepatic function, as defined by:
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 90 g/L
Plasma creatinine< 1.5 x ULN
Total bilirubin within normal limits (< 2.5 x ULN if Gilbert's syndrome)
Aspartate transaminase (AST) and Alanine transaminase (ALT) < 2.5 x ULN
Subject must be willing and able to understand the study and provide writtenInformed Consent to participate in the study
Exclusion
Exclusion Criteria:
Myocardial infarction within six months prior to enrollment
Unstable angina, NYHA Class II or greater congestive heart failure
EKG evidence of uncontrolled arrhythmia or history of clinically significantarrhythmia within the past six months
Clinically significant Chronic Obstructive Pulmonary Disease (COPD) or otherpulmonary condition that is not controlled by medication or requires oxygenfrequently or continuously
A history of pulmonary emboli
Known hypersensitivity to perflutren, DEFINITY® or other echo contrast agent
Inability to remain supine for 60 minutes
Oxygen saturation < 95% on room air
History of allergic reaction attributed to compounds of similar chemical compositionto MVT-100 or DEFINITY® or soy or egg allergies (see Investigator's Brochure)
Subject has received any investigational drug within thirty (30) days prior toenrollment into the study
Inability to comply with study procedures
Subjects with any medical condition deemed by the investigator to make the subjectinappropriate for participation
Study Design
Study Description
Connect with a study center
University of Arizona
Tucson, Arizona 85719
United StatesSite Not Available
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
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