Intellectual and Executive Functions in Relation to Cerebral MRI in Young Adults With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Intellectual performance
研究概览
简要总结
Research in children with congenital heart disease (CHD) requiring cardiopulmonary bypass surgery in the neonatal period or during early childhood has shown that the survival rate for this population has dramatically increased, also for those with the most severe forms of CHD. However, they are at significant risk for neurodevelopmental impairments, persisting into adolescence. Our research group showed that adolescents with CHD have smaller brain volumes than controls and that volume reduction correlates with poorer neurocognitive functioning. It is not known whether similar changes can also be found in adults with CHD (ACHD).
Aims:
- To determine intellectual and executive functions in young adults with congenital heart disease after childhood cardiopulmonary bypass surgery and to relate these findings to results on cerebral magnetic resonance imaging (MRI).
- To evaluate risk factors for adverse outcome and alteration on cerebral MRI.
- To examine the effect of poorer intellectual and executive functioning on academic achievement, quality of life, and psychosocial functioning.
Methodology:
Outcome variables: Intellectual and executive functioning as well as cerebral MRI.
Participants: Study subjects will be recruited from a large cohort that has been enrolled in a study on quality of life in ACHD. The investigators aim to include a maximum of 60 subjects per group (ACHD, controls). Variables and risk factors influencing outcome have already been assessed through that study. Cerebral MRI will be analysed for structural abnormalities, and volumetric, morphometric as well as connectivity analyses will be performed to comprehensively characterize cerebral architecture in ACHD and to compare it with that of healthy controls.
Inclusion criteria: Patients with congenital heart disease, cardiopulmonary bypass surgery during childhood, age 18 to 30 years Exclusion criteria: Known genetic syndromes or chromosomal abnormalities as well as other congenital or acquired diseases leading to mental disabilities, exclusion criteria for cerebral MRI.
详细描述
The overall aim of our project is to study intellectual and executive functions in relation to cerebral magnetic resonance imaging (MRI) in young adults with severe congenital heart disease (CHD). Risk factors for poorer function and altered brain structure will be examined. This will extend the knowledge on the spectrum of potential long-term impairments, risk factors and the effect on the patient's quality of life. Only a better understanding of the spectrum and contributing factors of neurocognitive impairments in adults will allow for an early therapy in childhood and will prevent or ameliorate long-term sequelae for patients with CHD.
Specific aims:
- To determine the intellectual and executive function of young adults with congenital heart disease after cardiopulmonary bypass surgery during infancy or childhood Hypothesis: Intellectual outcome is within the normal range but below that of controls and assume to find specific difficulties in certain areas of executive functions.
- To perform cerebral MRI and perform morphometric analyses Hypothesis: Cerebral volumes will be smaller and regional white matter microstructure will be altered, which correlate with intellectual and executive function
- To determine patient and medical risk factors associated with adverse outcome Hypothesis: Disease severity correlates with intellectual outcome.
- To determine the associations between intellectual and executive function and quality of life Hypothesis: Functional outcome correlates with quality of life.
Subjects:
The patients and controls have participated in a study on quality of life in adults with CHD and will be asked to return for this part of the study. So far, 180 patients and 145 controls have been enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Congenital heart disease
排除标准
- •Genetic condition
结局指标
主要结局
Intellectual performance
时间窗: 1.1.17-30.9.18
short version of the adult WISC form
Executive function global score
时间窗: 1.1.17-30.9.18
A score that is derived from averaging the T-values of the following executive function tests: color-word-interference test of the Delis-Kaplan-Executive Function System (D-KEFS) and the stop-signal task of the STOP-IT-both measuring inhibition, the S word of the Regensburger Wortflüssigkeitstest-measuring fluency, the Standardized Links' Probe-measuring planning, and the Trail Making Test -measuring cognitive flexibility. Value: Mean 50 (+/-10), higher value better performance
次要结局
- total brain volume on cerebral MRI(1.1.17-30.9.18)
研究者
Bea Latal
Prof. Bea Latal
University Children's Hospital, Zurich