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NCT05186415 · ClinicalTrials.gov registry record · Phase 1
Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
A Phase 1 study of Tetralogy of Fallot and Pulmonary Insufficiency, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05186415: Completed Phase 1 study of Tetralogy of Fallot and Pulmonary Insufficiency, sponsored by Nemours Children's Clinic.
NCT05186415 is a Phase 1 study of Tetralogy of Fallot and Pulmonary Insufficiency that has completed, run by Nemours Children's Clinic. The registered enrollment target is 25 participants, below the 186-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05186415, a Phase 1 study of Tetralogy of Fallot and Pulmonary Insufficiency, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Echocardiography derived measurements of right ventricular end-diastolic volume, end-systolic volume, with and without contrast, and MRI derived values in patients with repaired congenital heart disease
Conditions Studied
Interventions
- DRUG Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
Study Locations (1)
Delaware
- Nemours Childrens Hospital - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-08-23 |
| Est. Completion | 2024-06-25 |
| Phase | Phase 1 |
What the finished NCT05186415 record still lists
NCT05186415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 186-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Tetralogy of Fallot appearing as the primary indexed condition, and to 1 intervention - of which Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] is the first listed.
NCT05186415 reports a single indexed study location in Delaware.
Frequently Asked Questions
What is clinical trial NCT05186415 about?
NCT05186415 is a clinical study titled "Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD". 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 righ...
What is the current status of trial NCT05186415?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-08-23. Estimated completion is 2024-06-25.
What conditions does trial NCT05186415 study?
This clinical trial studies the following conditions: Tetralogy of Fallot, Pulmonary Insufficiency.
What interventions are being tested in trial NCT05186415?
The interventions under investigation include: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (DRUG).
Who is sponsoring clinical trial NCT05186415?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05186415 being conducted?
This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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