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NCT03070197 · ClinicalTrials.gov registry record
Genomic Basis of Neurodevelopmental and Brain Outcomes in Congenital Heart Disease (CHD Brain and Genes)
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 196
- Enrollment target
NCT03070197: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03070197 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 196 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03070197 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 196 participants
- Enrollment target
Study Summary
Approximately 400 Congenital heart disease patients will participate in the research study which will include one or more research visits for neurodevelopmental testing, brain MRI, and collection of medical history including previously collected genetic sequencing results. The investigators will explore the association between genetic variants, neurodevelopmental deficits, and brain MRI endophenotype. Analyses will compare groups with and without deleterious de novo mutations.
Primary Outcome
The investigators will compare groups with respect to achievement, IQ, learning disability, specific neuropsychological domains (e.g., memory, attention, executive functions, and visual-spatial/motor integration), adaptive function, behavior, social cognition and symptoms of autism spectrum disorder, and quality of life. The primary study outcome for this aim will be the WRAT4 composite score.
Interventions
- OTHER Exposure of interest: Brain MRI
- OTHER Exposure of interest: neurodevelopmental assessments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2020-06-29 |
What the finished NCT03070197 record still lists
NCT03070197 is an observational study that tracks outcomes without assigning an intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Exposure of interest: Brain MRI is the first listed.
NCT03070197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03070197 about?
NCT03070197 is a clinical study titled "Genomic Basis of Neurodevelopmental and Brain Outcomes in Congenital Heart Disease (CHD Brain and Genes)". Approximately 400 Congenital heart disease patients will participate in the research study which will include one or more research visits for neurodevelopmental testing, brain MRI, and collection of medical history including previously collected genetic sequencing results. The investigators will exp...
What is the current status of trial NCT03070197?
This trial is currently completed. The enrollment target is 196 participants. The study started on 2017-09-18. Estimated completion is 2020-06-29.
What interventions are being tested in trial NCT03070197?
The interventions under investigation include: Exposure of interest: Brain MRI (OTHER), Exposure of interest: neurodevelopmental assessments (OTHER).
Who is sponsoring clinical trial NCT03070197?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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