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

NCT04286100 | Active Not Recruiting

• 1 other identifier: CRC/2019/002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contrast Echocardiography Imaging

Keywords

Coronary artery disease; Myocardial contrast echocardiography; Left ventricle opacification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants enrolled in the Luminity 422 study that also have complete data with contrast specific imaging obtained within a 60 day window.
• Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

You may not qualify if:

• \. Unwilling / unable to give informed consent

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Roxy Senior

  LNWH Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 26, 2020
• Study Start: April 29, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)