Improving Care for Children With Congenital Heart Disease by Cardiovascular Biomarker Profiling and Advanced Non-invasive Cardiac Imaging Techniques.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Time from diagnosis to open-heart surgery or cardiac catheter intervention in predefined congenital heart disease lesions
研究概览
简要总结
Establish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for future cardiac interventions such as open heart surgery or cardiac catheter intervention in selected types of with congenital heart disease.
详细描述
Analysing circulating cardiovascular biomarkers using blood samples should improve identification of congenital heart disease in newborns, in particular for those needing future cardiac interventions.
Comparing such biomarker profiles and non-invasive cardiac imaging results over time in infants and children should lead to better understanding of the complex cardiovascular remodelling processes in common congenital heart lesions, such as atrial or ventricular septal defects. This in turn should lead to an improved risk factor assessment model to guide treatment decisions in children with congenital heart disease in the foreseeable future.
To test our hypothesis, that cardiovascular biomarker profiling and non-invasive cardiac imaging findings in infants and children with congenital heart disease, differs from healthy controls, we will assess controls at enrolment and follow cases with predefined congenital heart disease lesions over a maximum of three years or up till one year after open heart surgery / cardiac catheter intervention to correct such lesions.
Infants and children resident in designated healthcare regions of Sweden will be invited to participate after study advertisement. Written informed consent will be obtained from legal guardians and assent will be sought from children who can communicate verbally with the dedicated paediatric research team.
Healthy subjects 0-17 years at enrolment will undergo i.e. standard electrocardiogram (ECG), echocardiography and blood sampling to evaluate the heart's anatomy and function and to obtain samples for subsequent blood-based biomarker analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant and standard clinical care providers will be blinded to biomarker analyses and advanced cardiac imaging findings throughout the study
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •obtained written informed consent prior to enrolment
- •resident within participating healthcare regions in Sweden during study
- •age 0-17 years at enrolment
- •Controls: No evidence of congenital heart disease and no history of cardiovascular disease
- •Cases: congenital heart lesions prior to open heart surgery or cardiac catheter intervention with grouping into i.e. ventricular septal defects and atrial septal defects, complex and critical cases requiring infant surgery or patency of the arterial duct to maintain the circulation postnatally.
排除标准
- •inability to obtain written informed consent prior to study enrolment and/or comply with study protocol
- •non-resident in participating healthcare regions of Sweden during study
- •age more than 17 years at enrolment
- •presence of congenital heart disease where the lesion has already been treated by open heart surgery or cardiac catheter intervention
- •participation in other research study with conflicting aims / interests
研究组 & 干预措施
Control subjects
Infants and Children with no evidence of congenital heart disease based on clinical examination and echocardiography / standard ECG assessment where necessary.
Congenital heart disease subjects
Infants and Children with evidence of predefined congenital heart disease lesions based on clinical examination, echocardiography and standard ECG assessment
干预措施: Biomarker analysis at enrolment (Diagnostic Test)
Congenital heart disease subjects
Infants and Children with evidence of predefined congenital heart disease lesions based on clinical examination, echocardiography and standard ECG assessment
干预措施: Biomarker analyses throughout the study (Diagnostic Test)
结局指标
主要结局
Time from diagnosis to open-heart surgery or cardiac catheter intervention in predefined congenital heart disease lesions
时间窗: 3 years
Number of days from date of diagnosis of predefined congenital heart disease lesion until date of open-heart surgery or cardiac catheter intervention to treat lesion
次要结局
- Screening for congenital heart disease in newborns using circulating biomarkers in blood samples(3 years)
- Circulating cardiovascular protein biomarker profiling in infants and children with predefined congenital heart disease lesions vs normal controls using blood samples.(3 years)
- Measurement of cardiac magnetic resonance 4-dimensional flows to estimate 'kinetic energy' supported by advanced echocardiography in normal controls vs predefined lesions of congenital heart disease(3 years)
研究者
Henning Clausen, MD
Hennnig Clausen, MD
Lund University Hospital