Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-141

NCT02522481 | Completed Phase 3 Results

• 1 other identifier: BR1-141
• Study Type: interventional
• Target: 175
• Locations: 4 countries
• Sites: 17

Brief 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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity 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 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 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 left ventricular endocardial border delineation (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

  up to 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 was willing to comply with protocol requirements;
• Was at least 18 years of age;
• Had suspected or known CAD and was scheduled to undergo 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. Excluded 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 (17)

Sarver Heart Center, University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Interventional Cardiology Medical Group, Inc.

West Hills, California, 91037, United States

Location

Cardiology Physicians, PA

Newark, Delaware, 19713, United States

Location

Community Heart and Vascular Community Hospital East

Indianapolis, Indiana, 46250, United States

Location

St. Luke's Mid-America Heart Institute

Kansas City, Missouri, 64111, United States

Location

North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

The Institute for Clinical Research Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Mazankowski Alberta Heart Institute, University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

Medizinische Klinik m.S. Kardiologie und Angiologie, Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Klinikum Lünen, St. Marien-Hospital GmbH

Lünen, 44534, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Kardiologie Klinik Dr. Müller GmbH, Peter Osypka Heart Center

Munich, 81379, Germany

Location

Azienda Ospedaliera Universitaria Parma

Parma, 43126, Italy

Location

Azienda Policlinico Umberto I Università degli Studi di Roma La Sapienza

Rome, 00161, Italy

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: July 17, 2015
• First Posted: August 13, 2015
• Study Start: September 24, 2015
• Primary Completion: November 7, 2017
• Study Completion: February 25, 2018
• Last Updated: June 11, 2021
• Results First Posted: August 5, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); DE (4); US (10); IT (2)