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
153
All subjects will receive a single dose of DEFINITY®
Banner University of Arizona Medical Center
Tucson, Arizona, United States
University of California-San Diego
San Diego, California, United States
Alfieri Cardiology
Wilmington, Delaware, 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 Suboptimal 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 readers.
Time frame: Up to 30 days between day of echocardiograms 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 and 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 echocardiograms and CMR imaging
Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms
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Henry Ford Hospital
Detroit, Michigan, United States
Weill Cornell Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
University Hospital/Cleveland Medical Center
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
West Virginia University Medical Center
Morgantown, West Virginia, United States
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