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

Lantheus Medical Imaging131 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

131

Conditions

Ventricular Ejection Fraction

Interventions

Definity® Vial for (Perflutren Lipid Microsphere) Injectable SuspensionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

University of Arizona

Tucson, Arizona, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Washington Hospital Center

Washington DC, Maryland, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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