Cardiac Disease
Conditions
Keywords
Left Ventricular Ejection Fraction, DEFINITY, Enhanced Echocardiogram, Cardiac Magnetic Resonance
Brief summary
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.
Interventions
DRUGDEFINITY
All subjects will receive a single dose of DEFINITY®
Sponsors
Syneos Health
Lantheus Medical Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women ≥ 18 years of age in sinus rhythm 2. Able to communicate effectively with trial personnel 3. Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0) 4. Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -
Exclusion criteria
1. Female subjects who are pregnant or lactating. All women of child bearing potential \[WOCBP\] must have a negative urine pregnancy test at screening regardless of contraceptive use history. 2. Women of child-bearing potential are excluded unless they: 1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR 2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR 3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study. 3. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient. 4. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg). 5. Unstable cardiovascular status defined as: 1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day 2. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration 3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease 4. clinically significant congenital heart defects 5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise 6. acute pulmonary embolus or pulmonary infarction 7. acute myocarditis or pericarditis 8. acute aortic dissection 9. atrial fibrillation 6. any major surgery within 4 weeks prior to screening 7. known contraindications to undergoing CMR or claustrophobia 8. participation in any investigational drug, device, or placebo study within 30 days prior to screening 9. known hypersensitivity to perflutren, or any of the excipients in DEFINITY® 10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Up to 30 days between day of echocardiograms and CMR imaging | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms | Up to 30 days between day of echocardiograms and CMR imaging | 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. |
| Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Up to 30 days between day of echocardiograms and CMR imaging | 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 |
| Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Up to 30 days between day of echocardiograms and CMR imaging | 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. |
| Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Up to 30 days between day of echocardiograms and CMR imaging | 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. |
| Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Up to 30 days between day of echocardiograms and CMR imaging | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Definity Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound
DEFINITY: All subjects will receive a single dose of DEFINITY® | 153 |
| Total | 153 |
Baseline characteristics
| Characteristic | Definity |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 55 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| LVEF Group LVEF <30% | 35 Participants |
| LVEF Group LVEF 30-40% | 40 Participants |
| LVEF Group LVEF 41-50% | 39 Participants |
| LVEF Group LVEF >50% | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 104 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 153 |
| other Total, other adverse events | 0 / 153 |
| serious Total, serious adverse events | 0 / 153 |
Outcome results
Primary
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
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Reader 1 | Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Echo Enhanced | 6.10 Percent Ejection Fraction | Standard Deviation 5.319 |
| Blinded Reader 1 | Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Echo Unenhanced | 6.18 Percent Ejection Fraction | Standard Deviation 5.3 |
| Blinded Reader 2 | Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Echo Enhanced | 6.38 Percent Ejection Fraction | Standard Deviation 5.227 |
| Blinded Reader 2 | Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Echo Unenhanced | 6.61 Percent Ejection Fraction | Standard Deviation 5.256 |
| Blinded Reader 3 | Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Echo Enhanced | 4.93 Percent Ejection Fraction | Standard Deviation 4.288 |
| Blinded Reader 3 | Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Echo Unenhanced | 5.36 Percent Ejection Fraction | Standard Deviation 4.498 |
p-value: 0.868t-test, 2 sided
p-value: 0.606t-test, 2 sided
p-value: 0.224t-test, 2 sided
Secondary
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
Population: Per-protocol population - Sub-optimal Echocardiograms
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Reader 1 | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms | Echo Unenhanced | 7.16 Percent Ejection Fraction | Standard Deviation 6.184 |
| Blinded Reader 1 | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms | Echo Enhanced | 7.48 Percent Ejection Fraction | Standard Deviation 6.228 |
| Blinded Reader 2 | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms | Echo Unenhanced | 7.12 Percent Ejection Fraction | Standard Deviation 5.381 |
| Blinded Reader 2 | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms | Echo Enhanced | 7.16 Percent Ejection Fraction | Standard Deviation 6.337 |
| Blinded Reader 3 | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms | Echo Unenhanced | 5.89 Percent Ejection Fraction | Standard Deviation 4.523 |
| Blinded Reader 3 | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms | Echo Enhanced | 5.71 Percent Ejection Fraction | Standard Deviation 5.293 |
p-value: 0.715t-test, 2 sided
p-value: 0.956t-test, 2 sided
p-value: 0.771t-test, 2 sided
Secondary
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
Population: Per-Protocol Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Reader 1 | Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Echo Enhanced | 6.10 Percent Ejection Fraction | Standard Deviation 5.319 |
| Blinded Reader 1 | Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Echo Unenhanced | 6.18 Percent Ejection Fraction | Standard Deviation 0.164 |
| Blinded Reader 2 | Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Echo Enhanced | 6.38 Percent Ejection Fraction | Standard Deviation 5.227 |
| Blinded Reader 2 | Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Echo Unenhanced | 6.61 Percent Ejection Fraction | Standard Deviation 5.256 |
| Blinded Reader 3 | Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Echo Enhanced | 4.93 Percent Ejection Fraction | Standard Deviation 4.288 |
| Blinded Reader 3 | Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Echo Unenhanced | 5.36 Percent Ejection Fraction | Standard Deviation 4.498 |
Comparison: Inter-Reader Variability Echo Enhanced95% CI: [0.944, 0.97]
Comparison: Inter-Reader Variability Echo Unenhanced95% CI: [0.931, 0.964]
Comparison: Inter-Reader Variability Echo Enhanced95% CI: [0.941, 0.969]
Comparison: Inter-Reader Variability Echo Unenhanced95% CI: [0.909, 0.952]
Comparison: Inter-Reader Variability Echo Enhanced95% CI: [0.946, 0.972]
Comparison: Inter-Reader Variability Echo Unenhanced95% CI: [0.913, 0.954]
Secondary
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
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Reader 1 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Enhanced End Systolic | 33.56 mL | Standard Deviation 28.641 |
| Blinded Reader 1 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Enhanced End Diastolic | 52.31 mL | Standard Deviation 35.726 |
| Blinded Reader 1 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Unenhanced End Diastolic | 58.02 mL | Standard Deviation 38.483 |
| Blinded Reader 1 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Unenhanced End Systolic | 37.53 mL | Standard Deviation 30.016 |
| Blinded Reader 2 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Unenhanced End Systolic | 33.51 mL | Standard Deviation 28.079 |
| Blinded Reader 2 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Enhanced End Systolic | 29.93 mL | Standard Deviation 25.845 |
| Blinded Reader 2 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Unenhanced End Diastolic | 56.65 mL | Standard Deviation 37.766 |
| Blinded Reader 2 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Enhanced End Diastolic | 46.57 mL | Standard Deviation 33.785 |
| Blinded Reader 3 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Unenhanced End Systolic | 30.72 mL | Standard Deviation 23.534 |
| Blinded Reader 3 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Enhanced End Diastolic | 39.37 mL | Standard Deviation 26.206 |
| Blinded Reader 3 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Unenhanced End Diastolic | 48.07 mL | Standard Deviation 31.62 |
| Blinded Reader 3 | Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Echo Enhanced End Systolic | 26.01 mL | Standard Deviation 20.74 |
Comparison: Inter-reader Variability End Diastolic Echo Enhanced95% CI: [0.984, 0.992]
Comparison: Inter-reader Variability End Diastolic Echo Unenhanced95% CI: [0.981, 0.99]
Comparison: Inter-reader Variability End Diastolic Echo Enhanced95% CI: [0.945, 0.971]
Comparison: Inter-reader Variability End Diastolic Echo Unenhanced95% CI: [0.897, 0.945]
Comparison: Inter-reader Variability End Diastolic Echo Enhanced95% CI: [0.958, 0.978]
Comparison: Inter-reader Variability End Diastolic Echo Unenhanced95% CI: [0.876, 0.934]
Comparison: Inter-reader Variability End Systolic Echo Enhanced95% CI: [0.984, 0.992]
Comparison: Inter-reader Variability End Systolic Echo Unenhanced95% CI: [0.979, 0.989]
Comparison: Inter-reader Variability End Systolic Echo Enhanced95% CI: [0.962, 0.98]
Comparison: Inter-reader Variability End Systolic Echo Unenhanced95% CI: [0.927, 0.961]
Comparison: Inter-reader Variability End Systolic Echo Enhanced95% CI: [0.969, 0.984]
Comparison: Inter-reader Variability End Systolic Echo Unenhanced95% CI: [0.914, 0.954]
Secondary
Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms
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
Population: Per Protocol Population - Sub-Optimal Echocardiograms
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Reader 1 | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced | 7.48 Percent Ejection Fraction | Standard Deviation 6.228 |
| Blinded Reader 1 | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced | 7.16 Percent Ejection Fraction | Standard Deviation 6.184 |
| Blinded Reader 2 | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced | 7.16 Percent Ejection Fraction | Standard Deviation 6.337 |
| Blinded Reader 2 | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced | 7.12 Percent Ejection Fraction | Standard Deviation 5.381 |
| Blinded Reader 3 | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced | 5.71 Percent Ejection Fraction | Standard Deviation 5.293 |
| Blinded Reader 3 | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced | 5.89 Percent Ejection Fraction | Standard Deviation 4.523 |
Comparison: Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms95% CI: [0.909, 0.967]
Comparison: Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms95% CI: [0.864, 0.95]
Comparison: Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms95% CI: [0.9, 0.963]
Comparison: Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms95% CI: [0.827, 0.935]
Comparison: Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms95% CI: [0.92, 0.971]
Comparison: Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms95% CI: [0.838, 0.939]
Secondary
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
Population: Modified ITT population - Sub Optimal Echocardiograms
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blinded Reader 1 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced End Systolic | 39.52 mL | Standard Deviation 29.712 |
| Blinded Reader 1 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced End Systolic | 39.45 mL | Standard Deviation 33.303 |
| Blinded Reader 1 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced End Diastolic | 65.45 mL | Standard Deviation 43.227 |
| Blinded Reader 1 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced End Diastolic | 62.34 mL | Standard Deviation 40.035 |
| Blinded Reader 2 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced End Diastolic | 54.68 mL | Standard Deviation 37.571 |
| Blinded Reader 2 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced End Diastolic | 63.25 mL | Standard Deviation 41.7 |
| Blinded Reader 2 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced End Systolic | 33.97 mL | Standard Deviation 29.233 |
| Blinded Reader 2 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced End Systolic | 34.00 mL | Standard Deviation 26.955 |
| Blinded Reader 3 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced End Systolic | 32.78 mL | Standard Deviation 24.522 |
| Blinded Reader 3 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced End Diastolic | 45.44 mL | Standard Deviation 29.702 |
| Blinded Reader 3 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Unenhanced End Diastolic | 53.77 mL | Standard Deviation 34.21 |
| Blinded Reader 3 | Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms | Echo Enhanced End Systolic | 30.12 mL | Standard Deviation 22.174 |
Comparison: Inter-reader Variability End Diastolic Echo Enhanced95% CI: [0.961, 0.986]
Comparison: Inter-reader Variability End Diastolic Echo Unenhanced95% CI: [0.974, 0.991]
Comparison: Inter-reader Variability End Diastolic Echo Enhanced95% CI: [0.89, 0.96]
Comparison: Inter-reader Variability End Diastolic Echo Unenhanced95% CI: [0.77, 0.912]
Comparison: Inter-reader Variability End Diastolic Echo Enhanced95% CI: [0.914, 0.969]
Comparison: Inter-reader Variability End Diastolic Echo Unenhanced95% CI: [0.721, 0.892]
Comparison: Inter-reader Variability End Systolic Echo Enhanced95% CI: [0.97, 0.989]
Comparison: Inter-reader Variability End Systolic Echo Unenhanced95% CI: [0.957, 0.985]
Comparison: Inter-reader Variability End Systolic Echo Enhanced95% CI: [0.915, 0.969]
Comparison: Inter-reader Variability End Systolic Echo Unenhanced95% CI: [0.822, 0.933]
Comparison: Inter-reader Variability End Systolic Echo Enhanced95% CI: [0.932, 0.975]
Comparison: Inter-reader Variability End Systolic Echo Unenhanced95% CI: [0.794, 0.922]