CARES (Contrast EchocArdiography REgistry for Safety Surveillance): A Prospective, Phase IV, Open-Label, Nonrandomized, Multicenter, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

Lantheus Medical Imaging16 sites in 1 country1,060 target enrollmentFebruary 2008

ConditionsCardiovascular Disease

InterventionsDEFINITY®

DrugsDEFINITY®

Overview

Phase: Phase 4
Intervention: DEFINITY®
Conditions: Cardiovascular Disease
Sponsor: Lantheus Medical Imaging
Enrollment: 1060
Locations: 16
Primary Endpoint: The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

July 2009

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lantheus Medical Imaging

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

DEFINITY® (Perflutren Lipid Microsphere)

Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography

Intervention: DEFINITY®