Contrast Specific Echocardiogram Versus Left Ventricular Opacification (LVO) Imaging Settings

Contrast Echocardiography Imaging Clinical Trial

— ELVIS  

Official title:

Comparison of Image Quality Generated by Contrast Specific Echocardiogram and Left Ventricular Opacification (LVO) Imaging Settings in Patients Enrolled in Luminity 422 Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04286100
• Other study ID #: CRC/2019/002
• Status: Active, not recruiting
• Start date: April 29, 2020
• Est. completion date: March 2025

Study information

• Verified date: May 2023
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compares "contrast specific imaging setting" images with "left ventricular opacification (LVO)" images taken on the same group of patients at different points in time, to see if one is more effective at assessing the function of the heart.

Description:

Ultrasound testing of the heart using a "dye" or contrast is often used to get clear pictures of the heart in many heart conditions. When this test is done when the heart is working hard, such as when exercising, this is called contrast stress echocardiography.

Current guidelines recommend the method called "contrast specific imaging setting," as the best way of looking at the main pumping part of the heart. However, it is not known if it provides better pictures when compared to a different method called "left ventricular opacification (LVO)."

This study will compare pictures in patients who have had tests done using both ways of looking at the heart and will compare; LVO; enhanced and unenhanced LVEBD; LVO imaging with contrast specific imaging Wall Motion Classification and LVO to contrast specific imaging Left Ventricular Ejection Fraction (LVEF). The comparison will be done by a group of experts in cardiac ultrasound.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants enrolled in the Luminity 422 study that also have complete data with contrast specific imaging obtained within a 60 day window.

2. Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria:

1. Unwilling / unable to give informed consent

Related Conditions & MeSH terms

• Contrast Echocardiography Imaging

Locations

Country	Name	City	State
United Kingdom	Northwick Park Hospital	Harrow

Sponsors (2)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust	Lantheus Medical Imaging

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether the technique left ventricular opacification (LVO) imaging provide better quality images than current best practice "contrast specific imaging setting," in patients routinely referred for a transthoracic echocardiogram.		8 months
Secondary	To determine whether the technique LVO imaging provide better quality images than the current best practice for comparison of segmental LVEBD between images obtained by LVO imaging (intermediate MI) and contrast specific imaging (low MI).		8 months
Secondary	To determine whether the technique LVO imaging provide better quality images than the current best practice for comparison of wall motion classification between images obtained by LVO imaging (intermediate MI) and contrast specific imaging (low MI).		8 months
Secondary	To determine whether the technique LVO imaging provide better quality images than the current best practice for comparison of LVEF assessment between images obtained by LVO imaging (intermediate MI) and contrast specific imaging (low MI).		8 months