The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
0.062 mg/kg continuous IV infusion (100-250 mL/hr) during echocardiography, not to exceed 60 minutes infusion, single dose.
To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome
Time frame: 72 hours, 6 months
To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease.
Time frame: 72 hours, 6 months
To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD.
Time frame: 72 hours, 6 months
To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography
Time frame: 72 hours
To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone.
Time frame: 72 hours, 6 months
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