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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEFINITY | Experimental | Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEFINITY | Drug | All subjects will receive a single dose of DEFINITY® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days between day of echocardiograms and CMR imaging |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
Women of child-bearing potential are excluded unless they:
Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
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).
Unstable cardiovascular status defined as:
any major surgery within 4 weeks prior to screening
known contraindications to undergoing CMR or claustrophobia
participation in any investigational drug, device, or placebo study within 30 days prior to screening
known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
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) -
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | United States | ||
| University of California-San Diego |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data are calculated based on Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Modified ITT Population | Posted | Mean | Standard Deviation | Percent Ejection Fraction | Up to 30 days between day of echocardiograms and CMR imaging |
|
Up to 12 days: Enrolled subjects were followed for adverse events and serious adverse events from the time the Informed Consent was signed at screening (Day -7 to Day 0) through 72+/- 24 hours after completion of Definity administration (Day 0).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Definity | Each patient will undergo an unenhanced ultrasound examination and a single dose DEFINITY contrast-enhanced ultrasound during the same imaging session |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Istvan Molnar | Lantheus Medical Imaging, Inc | 978-671-8686 | istvan.molnar@lantheus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2018 | Aug 28, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2018 | Aug 28, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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| 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 | 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. | 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 | 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. | 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. | Up to 30 days between day of echocardiograms and CMR imaging |
| San Diego |
| California |
| 92037 |
| United States |
| Alfieri Cardiology | Wilmington | Delaware | 19803 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48208 | United States |
| Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University Hospital/Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| West Virginia University Medical Center | Morgantown | West Virginia | 26505 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| LVEF Group | Left Ventricular Ejection Fraction (LVEF) Percentage measured by Cardiac Magnetic Resonance (CMR) imaging | Count of Participants | Participants |
|
| OG002 | Blinded Reader 3 | Independent Blinded Reader 3 of 3 |
|
|
|
| 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. | Per-protocol population - Sub-optimal Echocardiograms | Posted | Mean | Standard Deviation | Percent Ejection Fraction | Up to 30 days between day of echocardiograms and CMR imaging |
|
|
|
|
| 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 | Per-Protocol Population | Posted | Mean | Standard Deviation | Percent Ejection Fraction | Up to 30 days between day of echocardiograms and CMR imaging |
|
|
|
|
| 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. | Modified ITT Population | Posted | Mean | Standard Deviation | mL | Up to 30 days between day of echocardiograms and CMR imaging |
|
|
|
|
| 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. | Per Protocol Population - Sub-Optimal Echocardiograms | Posted | Mean | Standard Deviation | Percent Ejection Fraction | Up to 30 days between day of echocardiograms and CMR imaging |
|
|
|
|
| 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. | Modified ITT population - Sub Optimal Echocardiograms | Posted | Mean | Standard Deviation | mL | Up to 30 days between day of echocardiograms and CMR imaging |
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| 0 |
| 153 |
| 0 |
| 153 |
| 0 |
| 153 |
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|
Paired t-test |
| 0.956 |
| Mean Difference (Final Values) |
| 0.05 |
| Standard Deviation |
| 6.526 |
| 2-Sided |
| Superiority |
Difference between Echo Enhanced and Echo Unenhanced |
| t-test, 2 sided | Paired t-test | 0.771 | Mean Difference (Final Values) | -0.17 | Standard Deviation | 4.584 | 2-Sided | Superiority | Difference between Echo Enhanced and Echo Unenhanced |
|
| Intra-class Correlation Coefficient |
| 0.950 |
| 2-Sided |
| 95 |
| 0.931 |
| 0.964 |
| Other |
| Inter-Reader Variability Echo Enhanced | Intra-class Correlation Coefficient | 0.957 | 2-Sided | 95 | 0.941 | 0.969 | Other |
| Inter-Reader Variability Echo Unenhanced | Intra-class Correlation Coefficient | 0.934 | 2-Sided | 95 | 0.909 | 0.952 | Other |
| Inter-Reader Variability Echo Enhanced | Intra-class Correlation Coefficient | 0.961 | 2-Sided | 95 | 0.946 | 0.972 | Other |
| Inter-Reader Variability Echo Unenhanced | Intra-class Correlation Coefficient | 0.937 | 2-Sided | 95 | 0.913 | 0.954 | Other |
|
| Echo Enhanced End Systolic |
|
| Echo Unenhanced End Systolic |
|
| Intra-class Correlation Coefficient |
| 0.986 |
| 2-Sided |
| 95 |
| 0.981 |
| 0.990 |
| Other |
| Inter-reader Variability End Diastolic Echo Enhanced | Intra-class Correlation Coefficient | 0.960 | 2-Sided | 95 | 0.945 | 0.971 | Other |
| Inter-reader Variability End Diastolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.925 | 2-Sided | 95 | 0.897 | 0.945 | Other |
| Inter-reader Variability End Diastolic Echo Enhanced | Intra-class Correlation Coefficient | 0.970 | 2-Sided | 95 | 0.958 | 0.978 | Other |
| Inter-reader Variability End Diastolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.909 | 2-Sided | 95 | 0.876 | 0.934 | Other |
| Inter-reader Variability End Systolic Echo Enhanced | Intra-class Correlation Coefficient | 0.989 | 2-Sided | 95 | 0.984 | 0.992 | Other |
| Inter-reader Variability End Systolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.985 | 2-Sided | 95 | 0.979 | 0.989 | Other |
| Inter-reader Variability End Systolic Echo Enhanced | Intra-class Correlation Coefficient | 0.973 | 2-Sided | 95 | 0.962 | 0.980 | Other |
| Inter-reader Variability End Systolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.947 | 2-Sided | 95 | 0.927 | 0.961 | Other |
| Inter-reader Variability End Systolic Echo Enhanced | Intra-class Correlation Coefficient | 0.977 | 2-Sided | 95 | 0.969 | 0.984 | Other |
| Inter-reader Variability End Systolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.937 | 2-Sided | 95 | 0.914 | 0.954 | Other |
|
| Intra-class Correlation Coefficient |
| 0.917 |
| 2-Sided |
| 95 |
| 0.864 |
| 0.950 |
| Other |
| Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms | Intra-class Correlation Coefficient | 0.939 | 2-Sided | 95 | 0.900 | 0.963 | Other |
| Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms | Intra-class Correlation Coefficient | 0.894 | 2-Sided | 95 | 0.827 | 0.935 | Other |
| Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms | Intra-class Correlation Coefficient | 0.952 | 2-Sided | 95 | 0.920 | 0.971 | Other |
| Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms | Intra-class Correlation Coefficient | 0.900 | 2-Sided | 95 | 0.838 | 0.939 | Other |
|
| Echo Enhanced End Systolic |
|
| Echo Unenhanced End Systolic |
|
| Intra-class Correlation Coefficient |
| 0.984 |
| 2-Sided |
| 95 |
| 0.974 |
| 0.991 |
| Other |
| Inter-reader Variability End Diastolic Echo Enhanced | Intra-class Correlation Coefficient | 0.933 | 2-Sided | 95 | 0.890 | 0.960 | Other |
| Inter-reader Variability End Diastolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.857 | 2-Sided | 95 | 0.770 | 0.912 | Other |
| Inter-reader Variability End Diastolic Echo Enhanced | Intra-class Correlation Coefficient | 0.948 | 2-Sided | 95 | 0.914 | 0.969 | Other |
| Inter-reader Variability End Diastolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.824 | 2-Sided | 95 | 0.721 | 0.892 | Other |
| Inter-reader Variability End Systolic Echo Enhanced | Intra-class Correlation Coefficient | 0.982 | 2-Sided | 95 | 0.970 | 0.989 | Other |
| Inter-reader Variability End Systolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.974 | 2-Sided | 95 | 0.957 | 0.985 | Other |
| Inter-reader Variability End Systolic Echo Enhanced | Intra-class Correlation Coefficient | 0.948 | 2-Sided | 95 | 0.915 | 0.969 | Other |
| Inter-reader Variability End Systolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.890 | 2-Sided | 95 | 0.822 | 0.933 | Other |
| Inter-reader Variability End Systolic Echo Enhanced | Intra-class Correlation Coefficient | 0.959 | 2-Sided | 95 | 0.932 | 0.975 | Other |
| Inter-reader Variability End Systolic Echo Unenhanced | Intra-class Correlation Coefficient | 0.872 | 2-Sided | 95 | 0.794 | 0.922 | Other |