18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sensitivity and Specificity for Detection or Exclusion of Coronary Artery Disease (CAD)Primary· Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography were performed
The diagnostic performance of the echocardiographic images was compared to the truth standard to determine sensitivity and specificity. A diagnosis of coronary artery disease (CAD) was determined for both the echo images and truth standard (positive diagnosis for CAD is defined as \>/= 50% stenosis of any vessel on coronary angiography or if no coronary angiography is performed the occurence of a cardiac event based on clinical information for up to 6 months post dose; otherwise the diagnosis is negative).
Results for sensitivity and specificity are reflected based on difference between contr
Sensitivity
Group
Value
95% CI
CE-DSE - UE-DSE
8.0
Specificity
Group
Value
95% CI
CE-DSE - UE-DSE
33.7
Reader-Specific Percentages of Participants Identified as Having a Critical Shift From Suboptimal to Optimal Echocardiographic ImagesPrimary· Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed
The percentage of subjects with suboptimal images (defined as \>= 2 adjacent segments with inadequate left ventricular endocardial border delineation (LV EBD) in any of the 3 apical views) at unenhanced stress echo converted to adequate (reduction of suboptimal segments in any of the 3 apical views) at contrast-enhanced stress echo
Group
Value
95% CI
Reader 1
84.4
74.4 – 91.7
Reader 2
93.7
87.9 – 97.2
Reader 3
78.8
67.0 – 87.9
Change in Total LV EBDSecondary· Participants were followed until they had coronary angiography or up to 6 months post dose to collect clinical information on cardiac events if no coronary angiography was performed
Measured as the change in the total LV EBD score based on the 17 segments, from peak stress unenhanced vs. peak stress contrast-enhanced. Total LV EBD score ranges from 0 to 34 and higher score is better outcome.
Reader 1
Group
Value
95% CI
UE-DSE
17.5
± 10.83
CE-DSE
28.1
± 8.32
Difference
10.6
± 11.98
Reader 2
Group
Value
95% CI
UE-DSE
13.4
± 8.57
CE-DSE
30.5
± 4.81
Difference
17.1
± 7.87
Reader 3
Group
Value
95% CI
UE-DSE
17.8
± 7.04
CE-DSE
23.6
± 7.47
Difference
5.8
± 9.17
Number of Participants With Adverse EventsSecondary· up to 72 hours post dose
To obtain safety data in subjects administered Lumason during echocardiography
Number of subjects with adverse events (AE)
Group
Value
95% CI
Lumason
21
Number of subjects with AEs by intensity - Mild
Group
Value
95% CI
Lumason
15
Number of subjects with AEs by intensity -Moderate
Group
Value
95% CI
Lumason
5
Number of subjects with AEs by intensity - Severe
Group
Value
95% CI
Lumason
1
Number of subjects with serious AEs
Group
Value
95% CI
Lumason
3
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events (AE) that occurred from the time the subject signed the Informed Consent Form (ICF) until 72 hours after the last administration of Lumason or until the subject underwent cardiac intervention, whichever came first, were listed [recorded], [with predose AEs flagged in the subject data listings.].
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (CE-DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Bracco Diagnostics, Inc
Last refreshed: 11 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02522481.