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

NCT02522481 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2021-06-11

Study results available
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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

Interventions

DRUG

Lumason

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

Sponsors & Collaborators

  • Bracco Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Melda Dolan, MD · Bracco Diagnostics, Inc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-24
Primary Completion
2017-11-07
Completion
2018-02-25

Countries

  • United States
  • Canada
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522481 on ClinicalTrials.gov