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

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00401687
First received: November 16, 2006
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Ventricular Ejection Fraction
Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: July 2006
Study Completion Date: April 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Veronica Lee, MD, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00401687     History of Changes
Other Study ID Numbers: DMP 115-412
Study First Received: November 16, 2006
Last Updated: May 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Reduced Heart Function

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

ClinicalTrials.gov processed this record on October 22, 2014