Impact of Congenital Heart Disease on Neurodevelopmental Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2023-08-01

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.

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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.

Conditions

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Heart Defects, Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Atrial septal defect

Patients with an open atrial septal defect, diagnosed in childhood

Magnetic Resonance Imaging

Intervention Type OTHER

Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)

Neuropsychological assessment

Intervention Type OTHER

A special designed neuropsychological test battery of validated tests to assess function of cognitive domains

Ventricular septal defect

Patients who had surgical closure of a ventricular septal defect in childhood

Magnetic Resonance Imaging

Intervention Type OTHER

Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)

Neuropsychological assessment

Intervention Type OTHER

A special designed neuropsychological test battery of validated tests to assess function of cognitive domains

Healthy control

Healthy, young adults matched on age, gender and education

Magnetic Resonance Imaging

Intervention Type OTHER

Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)

Neuropsychological assessment

Intervention Type OTHER

A special designed neuropsychological test battery of validated tests to assess function of cognitive domains

Interventions

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Magnetic Resonance Imaging

Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)

Intervention Type OTHER

Neuropsychological assessment

A special designed neuropsychological test battery of validated tests to assess function of cognitive domains

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes