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NCT02522481 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141
A Phase 3 study, sponsored by Bracco Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT02522481: Completed Phase 3 study, sponsored by Bracco Diagnostics.
NCT02522481 is a Phase 3 study that has completed, run by Bracco Diagnostics. The registered enrollment target is 175 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02522481, a Phase 3 study, has completed, sponsored by Bracco Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Lumason
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2015-09-24 |
| Est. Completion | 2018-02-25 |
| Phase | Phase 3 |
What the finished NCT02522481 record still lists
NCT02522481 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Lumason is the first listed.
NCT02522481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02522481 about?
NCT02522481 is a clinical study titled "Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141". 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.
What is the current status of trial NCT02522481?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2015-09-24. Estimated completion is 2018-02-25.
What interventions are being tested in trial NCT02522481?
The interventions under investigation include: Lumason (DRUG).
Who is sponsoring clinical trial NCT02522481?
This trial is sponsored by Bracco Diagnostics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02522481's enrollment target sits among peer trials
175 1440th of 2000 higher than 559 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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