Impact of Congenital Heart Disease on Neurodevelopmental Outcome

Study Overview
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Brief Summary
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The project aims toward clarifying the underlying mechanism and the long-term impact of congenital heart disease on neurodevelopment.

Detailed Description
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The project provides detailed information on the impact of congenital heart disease on neurodevelopmental outcome in adulthood. The study investigates if brain maturation and development, and the neurocognitive outcome is compromised in patients with atrial or ventricular septal defects more than 20 years after diagnosis and treatment. Data on brain morphology, brain tissue architecture, and resting-state function will be obtained by 3.0 Tesla MRI. Data on neurocognitive outcome will be obtained by a customized wide neuropsychological test battery. This study will clarify the extent of these patients' neurodevelopmental challenges and guide evaluate targeted interventions to alleviate potentially long-term effects.

Official Title
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The Impact of Congenital Heart Disease on Neurodevelopmental Outcome and Comorbidity in Adulthood

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* Other: Magnetic Resonance Imaging
* Other: Neuropsychological assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICD codes DX Q21.0 (VSD) or DX Q21.1 (ASD), surgically repaired VSD or open ASD Exclusion Criteria: lack of medical record, suffering from coronary artery disease or other congenital cardiac abnormalities, diagnosed syndromes, spontaneous closure of the atrial septum defect before inclusion-date, magnetic implants or non-MRI compatible foreign objects, pregnancy, lack of Danish language skills or suffering from severe lung disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atrial septal defect<br>Patients with an open atrial septal defect, diagnosed in childhood | Other: Magnetic Resonance Imaging<br>* Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)<br>Other: Neuropsychological assessment<br>* A special designed neuropsychological test battery of validated tests to assess function of cognitive domains<br>|
| Ventricular septal defect<br>Patients who had surgical closure of a ventricular septal defect in childhood | Other: Magnetic Resonance Imaging<br>* Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)<br>Other: Neuropsychological assessment<br>* A special designed neuropsychological test battery of validated tests to assess function of cognitive domains<br>|
| Healthy control<br>Healthy, young adults matched on age, gender and education | Other: Magnetic Resonance Imaging<br>* Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)<br>Other: Neuropsychological assessment<br>* A special designed neuropsychological test battery of validated tests to assess function of cognitive domains<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term impact of congenital heart disease on brain development | MRI analysis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term impact of congenital heart disease on neurocognitive outcome | Neuropsychological assessment | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic resonance imaging, Brain, Neuropsychology, Heart Defects, Congenital, Follow-Up Studies