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:
Lantheus Medical Imaging
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00401687
First received: November 16, 2006
Last updated: May 19, 2011
Last verified: May 2011
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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
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 |
ClinicalTrials.gov processed this record on May 16, 2013