CompletedPhase 1/2

Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD

United States25 participantsStarted 2022-08-23

Plain-language summary

We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI.

Who can participate

Age range

11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All patients aged 11 or greater with repaired congenital heart disease and residual pulmonary insufficiency who are referred to Nemours A.I. DuPont Hospital for Children for clinically indicated cardiac MRI will be eligible for inclusion.
. Informed written consent of parent or legal guardian.
. Informed written assent of subject, if appropriate.

Exclusion criteria

. Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study.
. History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values.

Timeframe: All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Function Compared to MRI Derived Values.

Timeframe: All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

Inter-rater Reliability of 3D Echocardiography Based Measurements of Right Ventricular Size and Function With and Without Contrast

Timeframe: All echocardiographic images obtained on the day of the study participation. Analysis done offline.

Trial details

NCT IDNCT05186415

SponsorNemours Children's Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-25

Results submitted2025-04-28

View on ClinicalTrials.gov More Tetralogy of Fallot trials

Plain-language summary

Who can participate

Age range

11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All patients aged 11 or greater with repaired congenital heart disease and residual pulmonary insufficiency who are referred to Nemours A.I. DuPont Hospital for Children for clinically indicated cardiac MRI will be eligible for inclusion.
. Informed written consent of parent or legal guardian.
. Informed written assent of subject, if appropriate.

Exclusion criteria

. Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study.
. History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)

What they're measuring

Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values.

Timeframe: All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Function Compared to MRI Derived Values.

Timeframe: All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

Inter-rater Reliability of 3D Echocardiography Based Measurements of Right Ventricular Size and Function With and Without Contrast

Timeframe: All echocardiographic images obtained on the day of the study participation. Analysis done offline.