Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-142

Summary

The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.

Timeline

Start

2015-10-12

Primary completion

2017-06-22

Completion

2018-02-25

Outcome

Met primary endpoint

registry NUMBER CE-DSE - UE-DSE: Sensitivity: 16.0 percentage of participants NCT02552238 ↗

registry analysis (superiority test); CE-DSE - UE-DSE; p = 0.0067; McNemar NCT02552238 ↗

registry NUMBER CE-DSE - UE-DSE: Specificity: 37.9 percentage of participants NCT02552238 ↗

registry analysis (superiority test); CE-DSE - UE-DSE; p <0.0001; McNemar NCT02552238 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumason	Diagnostic / imaging agent	2 ml	Intravenous

Indications