NCT02552238

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

Completed Phase 3 Results posted Last updated 7 July 2021

What this trial tests

Phase 3 trial testing Lumason in Coronary Artery Disease in 174 participants. Completed in 25 February 2018.

Timeline

12 October 2015

Primary endpoint
22 June 2017

25 February 2018

Quick facts

Lead sponsor	Bracco Diagnostics, Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	174
Start date	12 October 2015
Primary completion	22 June 2017
Estimated completion	25 February 2018
Sites	13 locations across Belgium, United Kingdom, Canada, United States

Drugs / interventions tested

• Lumason — full drug profile →

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Bracco Diagnostics, Inc — full company profile →

Who can join

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 of Lumason Enhanced Dobutamine Stress Echo (DSE) 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 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 was performed the occurence of a cardiac event based on clinical information for up to 6 months post dose; otherwise the diagnosis was negative). Results for sensitivity and specificity are reflected based on difference between contrast enhanced stress echo

Sensitivity

Group	Value	95% CI
CE-DSE - UE-DSE	16.0

Specificity

Group	Value	95% CI
CE-DSE - UE-DSE	37.9

Reader-Specific Percentages of Participants Identified as Having a Critical Shift From Suboptimal to Optimal Echocardiographic Images 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 was performed

The percentage of subjects with suboptimal images (defined as \>= 2 adjacent segments with inadequate 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	93.2	86.5 – 97.2
Reader 2	89.8	77.8 – 96.6
Reader 3	93.5	87.6 – 97.2

Change in Total LV EBD Secondary · 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	16.6	± 7.32
CE-DSE	30.7	± 4.30
Difference	14.1	± 7.35

Reader 2

Group	Value	95% CI
UE-DSE	20.5	± 8.36
CE-DSE	31.6	± 5.93
Difference	11.1	± 8.65

Reader 3

Group	Value	95% CI
UE-DSE	12.1	± 8.00
CE-DSE	29.5	± 7.06
Difference	17.3	± 9.20

Number of Participants With Adverse Events Secondary · 72 hours post dose

To obtain safety data in subjects administered Lumason during echocardiography

Number of subjects with AEs

Group	Value	95% CI
Lumason	18

Number of subjects with AEs by intensity - Mild

Group	Value	95% CI
Lumason	10

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	3

Number of subjects with serious AEs

Group	Value	95% CI
Lumason	3

Number of subjects who discontinued due to AE

Group	Value	95% CI
Lumason	2

Adverse events — posted to ClinicalTrials.gov

Time frame: All AEs that occurred from the time the subject signed the ICF until 72 hours after the last administration of Lumason or until the subject underwent cardiac intervention, whichever came first, were [recorded] listed, [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.

Lumason

Serious: 3/172 (2%)

Deaths: 0/172

Serious adverse events (3 terms)

Reaction	System	Lumason
Myocardial Ischemia	Cardiac disorders	—
Ventricular Fibrillation	Cardiac disorders	—
Electrocardiogram ST Segment Elevation	Investigations	—

Other adverse events (12 terms — click to expand)

Reaction	System	Lumason
Chest pain	General disorders	—
Nausea	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Hypoesthesia	Nervous system disorders	—
Atrial fibrillation	Cardiac disorders	—
Urinary tract infection	Infections and infestations	—
Blood creatinine increased	Investigations	—
Blood glucose increased	Investigations	—
Troponin increased	Investigations	—
Dysgeusia	Nervous system disorders	—
Panic attack	Psychiatric disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Myocardial Ischemia, Ventricular Fibrillation, Electrocardiogram ST Segment Elevation.

Data from ClinicalTrials.gov NCT02552238 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.