This trial is to compare PB127 echocardiography to other heart imaging studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
428
0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.
Heartcare, P.C.
Scottsdale, Arizona, United States
Mayo Clinic Scottsdale
To demonstrate the non-inferiority of the diagnostic performance of PB127 MCE versus stress SPECT in the detection and/or exclusion of significant obstructive CAD as defined by QCA or qualifying clinical outcome.
Time frame: 90 days
To assess the concordance of PB127 MCE with stress SPECT in differentiating between reversible vs. fixed defects in patients with significant obstructive CAD
Time frame: 28 days
To compare the diagnostic performance of PB127 MCE with stress SPECT in identifying the location of stenosis as identified by coronary angiography.
Time frame: 28 days
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Scottsdale, Arizona, United States
University of California San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
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Cardiovascular Consultants
Kansas City, Missouri, United States
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St Louis, Missouri, United States
...and 9 more locations