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Lumason in Dobutamine Stress Echocardiography for CAD
NCT02552238Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2015
- Primary completion
- Jun 2017
- Countries
- 4
- Sponsor
- Bracco Diagnostics Inc.
- Modality
- Small Molecules
- Drugs
- sulfur hexafluoride
- Conditions
- coronary artery disease (CAD)
01
Overview
Phase 3, open-label, single-arm trial of sulfur hexafluoride in coronary artery disease (CAD), sponsored by Bracco Diagnostics Inc. Primary endpoints: Sensitivity and Specificity of Lumason Enhanced Dobutamine Stress Echo (DSE) for Detection or Exclusion of Coronary Artery Disease (CAD) up to 6 months and Reader-Specific Percentages of Participants Identified as Having a Critical Shift From Suboptimal to Optimal Echocardiographic Images up to 6 months. Started Oct 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lumason
Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection during rest and stress echo
03
Who it enrols
Adult patients with suspected CAD scheduled for coronary angiography who have suboptimal unenhanced echocardiographic images at rest.
04
Endpoints
Primary
Sensitivity and Specificity of Lumason Enhanced Dobutamine Stress Echo (DSE) for Detection or Exclusion of Coronary Artery Disease (CAD)
Reader-Specific Percentages of Participants Identified as Having a Critical Shift From Suboptimal to Optimal Echocardiographic Images
Secondary
Change in Total Left Ventricular Endocardial Border Delineation (LV EBD)
Number of Participants With Adverse Events
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