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Impact of Congenital Heart Disease on Neurodevelopmental Outcome

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University of Aarhus

Status

Unknown

Conditions

Heart Defects, Congenital

Treatments

Other: Neuropsychological assessment
Other: Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT03871881
Brain&CHD

Details and patient eligibility

About

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

Full description

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.

Enrollment

120 patients

Sex

All

Ages

18 to 42 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

Atrial septal defect
Description:
Patients with an open atrial septal defect, diagnosed in childhood
Treatment:
Other: Neuropsychological assessment
Other: Magnetic Resonance Imaging
Ventricular septal defect
Description:
Patients who had surgical closure of a ventricular septal defect in childhood
Treatment:
Other: Neuropsychological assessment
Other: Magnetic Resonance Imaging
Healthy control
Description:
Healthy, young adults matched on age, gender and education
Treatment:
Other: Neuropsychological assessment
Other: Magnetic Resonance Imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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