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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00625365
First received: February 20, 2008
Last updated: October 14, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Cardiovascular Disease
Other: Perflutren Lipid Microspheres (DEFINITY®)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serious Adverse Events [ Time Frame: Through 24 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration


Enrollment: 1060
Study Start Date: February 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Perflutren Lipid Microspheres (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
    • Vial for (Perflutren Lipid Microsphere) injectable Suspension
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625365

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

No publications provided

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00625365     History of Changes
Other Study ID Numbers: DMP 115-415
Study First Received: February 20, 2008
Results First Received: December 17, 2010
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
DEFINITY
Safety
Survelliance

Additional relevant MeSH terms:
Cardiovascular Diseases
Definity
Perflutren
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014