DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function
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
1 other identifier
interventional
131
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2006
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 16, 2006
CompletedFirst Posted
Study publicly available on registry
November 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedMay 20, 2011
May 1, 2011
11 months
November 16, 2006
May 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.
Interventions
The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe valvular dysfunction
- Inability to remain supine for 30 minutes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of Arizona
Tucson, Arizona, 85727, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Washington Hospital Center
Washington DC, Maryland, 20010, United States
Saint Lukes Mid America Heart Institute
Kansas City, Missouri, 64111, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Study Officials
- STUDY DIRECTOR
Veronica Lee, MD
Lantheus Medical Imaging
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 16, 2006
First Posted
November 20, 2006
Study Start
July 1, 2006
Primary Completion
June 1, 2007
Study Completion
April 1, 2008
Last Updated
May 20, 2011
Record last verified: 2011-05