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

November 6, 2020 updated by: Lantheus Medical Imaging

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1060

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103-8411
        • UCSD Medical Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Alfieri Cardiology
    • Illinois
      • Chicago, Illinois, United States, 60611-2969
        • Northwestern University
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicolett Institute
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Cardiovascular Consultants, P.C.
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University
    • New York
      • New York, New York, United States, 10029
        • Mt Sinai Medical Center
      • New York, New York, United States, 10025
        • St. Luke's-Roosevelt Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Meritcare Heart Center Cardiology
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • York, Pennsylvania, United States, 17405
        • York Hospital
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Consultants in Cardiology
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Center
      • Houston, Texas, United States, 77030
        • The Methodist DeBakey Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Drug: DEFINITY®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during or within 30 minutes of administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through 24 hours
Adverse Events
Time Frame: Through 24 hours
Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration
Through 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lantheus Medical Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMP 115-415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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