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DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00401687
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Lantheus Medical Imaging

Brief Summary:
The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).

Condition or disease Intervention/treatment Phase
Ventricular Ejection Fraction Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter, Phase IV Study to Evaluate the Ability of Definity® Enhanced Versus Unenhanced Echocardiography to Improve the Accuracy and Reproducibility of Left Ventricular Ejection Fraction When Compared to Cardiac Magnetic Resonance Imaging
Study Start Date : July 2006
Primary Completion Date : June 2007
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren
U.S. FDA Resources


Intervention Details:
    Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
    The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.


Primary Outcome Measures :
  1. Demonstrate the ability of Definity® enhanced versus unenhanced echocardiography to improve the accuracy of left ventricular ejection fraction when compared to cardiac magnetic resonance imaging (MRI) in a blinded assessment [ Time Frame: Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects 18 years of age or older
  • Have a documented EF value ranging from 25% to 40%
  • Have been scheduled to undergo or have undergone a cardiac MRI study

Exclusion Criteria:

  • Severe valvular dysfunction
  • Inability to remain supine for 30 minutes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401687


Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85727
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
Washington Hospital Center
Washington DC, Maryland, United States, 20010
United States, Missouri
Saint Lukes Mid America Heart Institute
Kansas City, Missouri, United States, 64111
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Veronica Lee, MD Lantheus Medical Imaging

Responsible Party: Veronica Lee, MD, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00401687     History of Changes
Other Study ID Numbers: DMP 115-412
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

Keywords provided by Lantheus Medical Imaging:
Reduced Heart Function