At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 160 enrolled
Drug / intervention
DEFINITY®drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY®-Enhanced 2D-Echo and Magnetic Resonance Imaging
In Brief
A Phase 3 clinical trial evaluating DEFINITY® for Cardiac Disease. Completed, enrolled 160 participants across 15 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Disease
CountriesUnited States
CollaboratorsSyneos Health
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartDec 2018
Primary CompletionJan 2020
TodayJul 2026
First PostedOct 25, 2018
Enrollment StartDec 28, 2018
Primary CompletionJan 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.7 years ago
Interventions
DEFINITY®drug
All subjects will receive a single dose of DEFINITY®