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OpenTrials
Completed

NCT Number: NCT00401687

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

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).

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Key information

Conditions

Ventricular Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Arizona, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

Drug

The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.

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

    Time frame: Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 20, 2006
Registry last updated
May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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