Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease -Improving the Assessment, Monitoring and Prediction in Children
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- CMR measures
研究概览
简要总结
The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates.
The main question[s] it aims to answer are:
- [question 1]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve
- [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term.
Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.
详细描述
Background:
An increasing number of children with complex congenital heart disease (CHD) are today treated and survive into adulthood. They are in need of a lifelong surveillance for cardiovascular complications and an individualised treatment.
In paediatric aortic and pulmonary valve disease, the long-term complications are related to valvular dysfunction with myocardial fibrosis and ventricular dysfunction as a result of longstanding volume or pressure overload. Many patients will need surgery or interventional treatment already in childhood, where the optimal timing of the intervention is crucial, since early treatment may prevent irreversible injury to the heart.
Moreover, to enable detection of recurrent or new problems early, a long-term diagnostic follow-up is needed where cardiovascular magnetic resonance (CMR) has become important for a serial reproducible assessment of morphology, function and recently advanced methods for flow and tissue characterisation. Still the the clinical decision of the perfect time-point and type of treatment for a child, may be difficult in many cases, and better measures are needed.
Aim:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Week 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aortic valve disease
- •or pulmonary valve disease
- •clinical indication for valvular surgery
- •or clinical indication for valvular intervention
排除标准
- •contraindications for MRI
- •need of sedation or general anesthesia, unless there is a clinical indication for a CMR
结局指标
主要结局
CMR measures
时间窗: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
Measurement by CMR of changes in ventricular function, remodelling, tissue characterisation and advanced four dimensional flow (4D-flow) measurements after surgery or intervention
Physical capacity
时间窗: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
Measurement of physical capacity after surgery or intervention, by cardiopulmonary exercise testing (CPET)
次要结局
- CMR derived flow measurements near metallic implants, stents(after 6 months, 1 year and up to 3 years after intervention)
研究者
Charlotte de Lange
MD Associate Professor, senior consultant
Sahlgrenska University Hospital