Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Congenital Heart Disease
Tetralogy of Fallot, Pulmonary Insufficiency
About this trial
This is an interventional diagnostic trial for Tetralogy of Fallot focused on measuring ultrasound enhancing agent, echocardiography, lumason
Eligibility Criteria
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 hexaflouride, 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.
Sites / Locations
- Nemours Childrens HospitalRecruiting
Arms of the Study
Arm 1
Experimental
diagnostic arm
The echocardiography team will perform baseline echocardiographic views of the right ventricle without contrast. The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations. Dosages and timing of administration as well as patient size and transducer type will be recorded for each patient. The total cumulative dose of Lumason from the clinical study and the research study will not exceed the maximum recommended dose by the manufacturer, 4.8 mL. A single injection will not exceed the maximal FDA-recommended dose of 2.4 mL per single injection. These echocardiographic views of the right ventricle with ultrasound enhancing agent will be compared to the measurements made without the use of ultrasound enhancing agents, and the measurements made in MRI.