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 range11 Years

SexALL

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)
✕. Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.

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 range11 Years

SexALL

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)
✕. Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.

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.