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NCT03571672 · ClinicalTrials.gov registry record · Phase 3
DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
A Phase 3 study of Cardiac Disease, sponsored by Lantheus Medical Imaging.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
- 9
- Study locations
NCT03571672: Completed Phase 3 study of Cardiac Disease, sponsored by Lantheus Medical Imaging.
NCT03571672 is a Phase 3 study of Cardiac Disease that has completed, run by Lantheus Medical Imaging. The registered enrollment target is 153 participants, below the 816-participant average among 24 other Cardiac Disease trials with a reported enrollment target (81% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03571672, a Phase 3 study of Cardiac Disease, has completed, sponsored by Lantheus Medical Imaging.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG DEFINITY
Study Locations (9)
Arizona
- Banner University of Arizona Medical Center - Tucson
California
- University of California-San Diego - San Diego
Delaware
- Alfieri Cardiology - Wilmington
Michigan
- Henry Ford Hospital - Detroit
New York
- Weill Cornell Medical Center - New York
North Carolina
- Duke University - Durham
Ohio
- University Hospital/Cleveland Medical Center - Cleveland
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 3 |
What the finished NCT03571672 record still lists
NCT03571672 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 816-participant average among 24 other Cardiac Disease trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Cardiac Disease appearing as the primary indexed condition, and to 1 intervention - of which DEFINITY is the first listed.
NCT03571672 lists 9 locations in 9 states (Arizona, California, Delaware).
Frequently Asked Questions
What is clinical trial NCT03571672 about?
NCT03571672 is a clinical study titled "DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY". 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 t...
What is the current status of trial NCT03571672?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2018-10-24. Estimated completion is 2019-08-30.
What conditions does trial NCT03571672 study?
This clinical trial studies the following conditions: Cardiac Disease.
What interventions are being tested in trial NCT03571672?
The interventions under investigation include: DEFINITY (DRUG).
Who is sponsoring clinical trial NCT03571672?
This trial is sponsored by Lantheus Medical Imaging, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03571672 being conducted?
This trial has 9 study locations across Arizona, California, Delaware, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiac Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03571672's enrollment target sits among peer trials
153 12th of 24 higher than 11 of 24 other Cardiac Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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