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NCT02919956 · ClinicalTrials.gov registry record
Cerebral Anatomy, Hemodynamics and Metabolism
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- 121
- Enrollment target
NCT02919956: Completed study, sponsored by Children's Hospital of Philadelphia.
NCT02919956 is a clinical trial that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 121 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02919956 has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- 121 participants
- Enrollment target
Study Summary
Single ventricle lesions are the leading cause of illness and death from congenital heart disease. The modified Fontan Operation is the corrective surgery for these lesions. The operation is done in stages over a few years and children who complete the operation are known to have greater neurodevelopmental (ND) deficits than the general population. The purpose of this study is to understand how blood flow to the brain (CBF) and brain lesions relate to ND outcome, as well as how CMRO2 relates to anatomic brain lesions. These relationships will be studied through Magnetic Resonance Imaging (MRI) and ND Testing.
Primary Outcome
This study proposes to recall SV patients from a cohort from a previous study to undergo an MRI (for anatomy, CBF and CMRO2) and ND testing. Normals from a previous grant will also be recalled to undergo ND testing. Correlations will be performed between ND, CBF and brain abnormalities from the a) original MRI, b) current study and c) change between the two. Response to hypercarbia will be assessed in a select group of patients. Additional SV patients and normals will be recruited to enrich the
Interventions
- OTHER Magnetic Resonance Imaging
- OTHER Neurodevelopmental Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2016-04 |
| Est. Completion | 2022-12-09 |
What the finished NCT02919956 record still lists
NCT02919956 is an observational study that tracks outcomes without assigning an intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT02919956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02919956 about?
NCT02919956 is a clinical study titled "Cerebral Anatomy, Hemodynamics and Metabolism". Single ventricle lesions are the leading cause of illness and death from congenital heart disease. The modified Fontan Operation is the corrective surgery for these lesions. The operation is done in stages over a few years and children who complete the operation are known to have greater neurodevelo...
What is the current status of trial NCT02919956?
This trial is currently completed. The enrollment target is 121 participants. The study started on 2016-04. Estimated completion is 2022-12-09.
What interventions are being tested in trial NCT02919956?
The interventions under investigation include: Magnetic Resonance Imaging (OTHER), Neurodevelopmental Testing (OTHER).
Who is sponsoring clinical trial NCT02919956?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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