Trial · NCT03719612
DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
NCT03719612, Phase 3, Completed, Lantheus Medical Imaging; results first posted 2021-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY. Trials, record NCT03719612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03719612
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
- NCT number
- NCT03719612
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 160 participants, actual
- Lead sponsor
- Lantheus Medical Imaging
- Conditions
- Cardiac Disease
- Interventions
- DEFINITY®
- First posted
- 2018-10-25
- Last updated
- 2021-01-28
- Results first posted
- 2021-01-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms | Up to 30 days between day of echocardiogram 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 blinded readers. |
| Secondary | 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 | Secondary Objective 3: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Up to 30 days between day of echocardiogram 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. |
| Secondary | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Readers for Sub-optimal 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 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Up to 30 days between day of echocardiograms and CMR imaging | Modified ITT Population | Percent Ejection Fraction | MEAN |
| SECONDARY | Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms | Up to 30 days between day of echocardiogram and CMR imaging | Modified ITT Population - Sub-optimal Echocardiograms | Percent Ejection Fraction | MEAN |
| SECONDARY | Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers | Up to 30 days between day of echocardiograms and CMR imaging | Modified ITT Population | Percent Ejection Fraction | MEAN |
| SECONDARY | Secondary Objective 3: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers | Up to 30 days between day of echocardiogram and CMR imaging | Modified ITT Population | mL | MEAN |
| SECONDARY | Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Readers for Sub-optimal Echocardiograms | Up to 30 days between day of echocardiograms and CMR imaging | Modified ITT Population - Sub-optimal Echocardiograms | Percent Ejection Fraction | MEAN |
| SECONDARY | 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 | Modified ITT Population - Sub-optimal Echocardiograms | mL | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Blinded Reader 1 | Echo Enhanced | 5.70 | Standard Deviation 4.292 | Percent Ejection Fraction |
| Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Blinded Reader 2 | Echo Enhanced | 5.88 | Standard Deviation 4.330 | Percent Ejection Fraction |
| Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Blinded Reader 3 | Echo Enhanced | 5.03 | Standard Deviation 3.548 | Percent Ejection Fraction |
| Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Blinded Reader 1 | Echo Unenhanced | 6.08 | Standard Deviation 4.530 | Percent Ejection Fraction |
| Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Blinded Reader 2 | Echo Unenhanced | 6.00 | Standard Deviation 4.813 | Percent Ejection Fraction |
| Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader | Blinded Reader 3 | Echo Unenhanced | 5.36 | Standard Deviation 3.889 | Percent Ejection Fraction |
| Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms | Blinded Reader 1 | Echo Enhanced | 5.67 | Standard Deviation 3.717 | Percent Ejection Fraction |
| Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms | Blinded Reader 2 | Echo Enhanced | 6.16 | Standard Deviation 3.746 | Percent Ejection Fraction |
| Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms | Blinded Reader 3 | Echo Enhanced | 4.68 | Standard Deviation 3.456 | Percent Ejection Fraction |
| Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms | Blinded Reader 1 | Echo Unenhanced | 6.95 | Standard Deviation 5.219 | Percent Ejection Fraction |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DEFINITY® | 160 | |
| Overall Study | COMPLETED | DEFINITY® | 148 | |
| Overall Study | NOT COMPLETED | DEFINITY® | 12 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Small intestinal obstruction | Gastrointestinal disorders | DEFINITY® | 1 | 160 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DEFINITY® | 0 | 160 |
| Total, other adverse events | DEFINITY® | 0 | 160 |
| Total, serious adverse events | DEFINITY® | 1 | 160 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03719612
GET https://conductscience.org/api/trials/v1/NCT03719612/results?page=2