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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Contrast Echocardiography Imaging

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Northwick Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From the 120 patients enrolled in the Luminity 422 clinical trial a cohort of participants underwent independent contrast specific imaging as part of their clinical management, during the time of recruitment for the trial. The contrast specific imaging data of these patients will be used.

Sixty participants from the total of one hundred twenty patients that participated in the Luminity 422 clinical trial are planned to be enrolled in the study. They will have undergone further clinical echocardiographic assessment for other clinical reasons using the recommended contrast specific imaging setting by the same vendor.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: London North West Healthcare NHS Trust
• Collaborators: Lantheus Medical Imaging
• Investigators: Principal Investigator: Roxy Senior, LNWH Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Coronary artery disease; Myocardial contrast echocardiography; Left ventricle opacification
• Other Study ID Numbers: CRC/2019/002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No