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

NCT02552238 | Completed Phase 3 Results

• 1 other identifier: BR1-142
• Study Type: interventional
• Target: 174
• Locations: 4 countries
• Sites: 13

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Lumason; Dobutamine stress echo; stress echo; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity of Lumason Enhanced Dobutamine Stress Echo (DSE) for Detection or Exclusion of Coronary Artery Disease (CAD)

  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 and unenhanced stress echo. Results for analysis of data based on majority assessment from the three off-site blinded readers are presented. Sensitivity and specificity are the percentages of correctly diagnosed subjects by stress echo over the total positive and negative subjects according to the truth standard respectively.

  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

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

  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

  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

Secondary Outcomes (2)

• Change in Total LV EBD

  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

• Number of Participants With Adverse Events

  72 hours post dose

Study Arms (1)

Lumason

EXPERIMENTAL

Lumason (sulfur hexafluoride lipid-type A microspheres) 2 mL IV injection

Drug: Lumason

Interventions

Lumason DRUG

Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography

Also known as: SonoVue

Lumason

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written Informed Consent and comply with protocol requirements;
• Was at least 18 years of age;
• Had suspected of having CAD and undergoing coronary angiography within 6 months after the LUMASON DSE.
• Had undergone a previous echocardiography prior to enrollment; resulting in suboptimal unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical view.

You may not qualify if:

• Was a pregnant or lactating female. Exclude the possibility of pregnancy: by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of LUMASON administration(s), by surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses;
• Had any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON);
• Had any known hypersensitivity to dobutamine;
• Had an ongoing or recent (within the last 30 days) acute myocardial infarction;
• Had known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON);
• Had electrolyte (especially potassium and magnesium) abnormalities;
• Had unstable pulmonary and/or systemic hemodynamic conditions e.g.:
• decompensated or inadequately controlled congestive heart failure (NYHA Class IV);
• hypovolemia;
• uncontrolled hypertension, i.e. resting systolic blood pressure \>200 mmHg or diastolic blood pressure \>110 mmHg;
• unstable angina;
• acute coronary syndrome;
• aortic dissection;
• acute pericarditis,
• myocarditis, or endocarditis;

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (13)

Coastal Multi-Specialty Research, Coastal Heart Medical Group

Santa Ana, California, 92704, United States

Location

Alfieri Cardiology

Wilmington, Delaware, 19803, United States

Location

Homestead Cardiac and Vein Center

Homestead, Florida, 33030, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Duke University Medical Center Cardiac Diagnostic Unit

Durham, North Carolina, 27710, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Cliniques Universitaires Saint-Luc Unité de Pathologie Cardio-Vasculaire / Cardiologie

Brussels, 1200, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Melda S. Dolan, MD, FACC, FASE, Head, Medical Affairs and Cardiac Ultrasound
• Organization: Bracco Diagnostics Inc.

Melda.Dolan@diag.bracco.com

1-609-514-2506

Study Officials

• Melda Dolan, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: September 17, 2015
• Study Start: October 12, 2015
• Primary Completion: June 22, 2017
• Study Completion: February 25, 2018
• Last Updated: July 7, 2021
• Results First Posted: August 5, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); CA (1); GB (2); US (8)