This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
160
All subjects will receive a single dose of DEFINITY®
Banner University of Arizona Medical Center
Tucson, Arizona, United States
Cedars Sinai
Los Angeles, California, United States
Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader
Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using DEFINITY® contrast-enhanced over unenhanced echocardiography by comparing LVEF percentage differences from CMR measured by 3 independent blinded image readers.
Time frame: Up to 30 days between day of echocardiograms and CMR imaging
Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms
Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using DEFINITY® contrast-enhanced over unenhanced echocardiography in subjects with suboptimal echocardiograms by comparing LVEF percentage differences from CMR measured by 3 independent blinded readers.
Time frame: Up to 30 days between day of echocardiogram and CMR imaging
Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers
Demonstrate a reduction in inter-reader variability for the assessment of left ventricular ejection fraction using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing LVEF percentage differences from CMR between 3 independent blinded readers.
Time frame: Up to 30 days between day of echocardiograms and CMR imaging
Secondary Objective 3: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers
Demonstrate a reduction in inter-reader variability for the assessment of end-diastolic/systolic volumes using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing end-diastolic and systolic volume differences from CMR between 3 independent blinded readers.
Time frame: Up to 30 days between day of echocardiogram and CMR imaging
Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Readers for Sub-optimal Echocardiograms
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University of California-Irvine
Orange, California, United States
UC San Diego
San Diego, California, United States
Alfieri Cardiology
Wilmington, Delaware, United States
Northwestern Medical Group
Chicago, Illinois, United States
Indiana University
Bloomington, Indiana, United States
Baptist Hospital
Paducah, Kentucky, United States
Mercy Unit Hospital
Coon Rapids, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 5 more locations
Demonstrate a reduction in inter-reader variability for the assessment of left ventricular ejection fraction using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing LVEF percentage differences from CMR between 3 independent blinded readers in subjects with suboptimal echocardiograms.
Time frame: Up to 30 days between day of echocardiograms and CMR imaging
Secondary Objective 5: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms
Demonstrate a reduction in inter-reader variability for the assessment of end-diastolic/systolic volumes using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing end-diastolic and systolic volume differences from CMR between 3 independent blinded readers in subjects with suboptimal echocardiograms.
Time frame: Up to 30 days between day of echocardiograms and CMR imaging