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

Phase 4

Completed

• Conditions: Ventricular Ejection Fraction

• Registration Number: NCT00401687
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Primary Completion: 2007-06
• Study Completion: 2008-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-19
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Saint Lukes Mid America Heart Institute; 🇺🇸 Kansas City, Missouri, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Washington Hospital Center; 🇺🇸 Washington DC, Maryland, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States