A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

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

Completed

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSD Medical Center, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.

Exclusion criteria

Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.

Treatment and study plan

DEFINITY®

Drug

DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert

Other names: DEFINITY, Perflutren Lipid Microsphere injectable suspension

Primary outcomes

The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration

Time frame: during or within 30 minutes of administration

Secondary outcomes

Serious Adverse Events

Time frame: Through 24 hours

Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration
Adverse Events

Time frame: Through 24 hours

Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Feb 28, 2008
Registry last updated: Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed