Contrast Echocardiography ImagingELVISNCT04286100
Contrast Specific Echocardiogram Versus Left Ventricular Opacification (LVO) Imaging Settings
An observational study of Contrast Echocardiography Imaging, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Echocardiography Imaging
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2020to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. Unwilling / unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Contrast Echocardiography Imaging
- Keywords
- Coronary artery disease, Myocardial contrast echocardiography, Left ventricle opacification
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start29 Apr 2020
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Echocardiography ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Sponsor
- Investigators
- Roxy Senior, Principal investigator, LNWH Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286100
- Sponsor's protocol ID
- CRC/2019/002
- Acronym
- ELVIS
- Status last verified
- May 2025
- First submitted
- 13 Jan 2020
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04286100
- Acronym / sponsor ID
- ELVIS / CRC/2019/002
- Conditions
- Contrast Echocardiography Imaging
- Keywords
- Coronary artery disease, Myocardial contrast echocardiography, Left ventricle opacification
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Unwilling / unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 8 months
3 secondary outcomes
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).
Time frame: 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).
Time frame: 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).
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxy Senior principal investigator
LNWH Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Echocardiography Imaging, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.