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3D Echocardiography for Congenital Heart Defects

Phase 1 & 2
Recruiting
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of initial assessment
Awards & highlights

Study Summary

This trial uses two echocardiographic technologies to improve accuracy of measures of right ventricular size and function, compared with MRI.

Who is the study for?
This trial is for individuals aged 11 or older with repaired congenital heart disease and residual pulmonary insufficiency who need a cardiac MRI. Participants must provide informed consent, and if under legal age, assent along with parental or guardian consent. Those allergic to Lumason or its components, with prior severe reactions to similar agents, or pregnant women cannot join.Check my eligibility
What is being tested?
The study tests the use of three-dimensional echocardiography combined with an ultrasound enhancing agent called Lumason against cardiac MRI for measuring right ventricular size and function in patients with repaired congenital heart defects.See study design
What are the potential side effects?
Potential side effects from Lumason may include allergic reactions such as rash, difficulty breathing, swelling of face or lips; however, these are more likely in those already sensitive to its ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 11 or older with repaired heart defects and need a heart MRI at Nemours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of initial assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of initial assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of 3D echocardiography based measurements of right ventricular size and function compared to MRI derived values.
Inter-rater reliability of 3D echocardiography based measurements of right ventricular size and function with and without contrast
Secondary outcome measures
Echocardiography

Trial Design

1Treatment groups
Experimental Treatment
Group I: diagnostic armExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
124 Previous Clinical Trials
18,091 Total Patients Enrolled
Nemours Children's Health SystemLead Sponsor
9 Previous Clinical Trials
17,371 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
443 Previous Clinical Trials
145,440 Total Patients Enrolled

Media Library

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Tetralogy of Fallot Research Study Groups: diagnostic arm
Tetralogy of Fallot Clinical Trial 2023: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] Highlights & Side Effects. Trial Name: NCT05186415 — Phase 1 & 2
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] 2023 Treatment Timeline for Medical Study. Trial Name: NCT05186415 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this clinical trial?

"According to information disseminated on clinicaltrials.gov, recruitment of participants is underway. The trial was inaugurated on August 23rd 2022 and the data was last refreshed on September 5th 2022."

Answered by AI

What is the upper limit of participants in this research project?

"Yes, according to clinicaltrials.gov the trial that began on August 23rd 2022 is still recruiting participants. As of September 5th 2022, the study requires 60 individuals from a single site to complete the research."

Answered by AI
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~8 spots leftby Jul 2024