Cardiovascular Magnetic Resonance at Rest and Stress in Relation to Cardiopulmonary Exercise Capacity in Young Adults After Arterial Switch Operation (ASO) for Transposition of the Great Arteries (TGA)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Ejection Fraction (EF)
研究概览
简要总结
Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of the great arteries.
详细描述
After ASO obstruction of the transposed coronary arteries with resulting reduced perfusion of the heart at stress or abnormities of the right ventricular blood flow resulting in increasing heart rate as well as abnormities in pulmonary flow can appear. In this single centre trial a large homogeneous group of young adults after surgery for transposition of the great arteries (TGA), the so called artery switch operation (ASO), will undergo magnetic resonance imaging (MRI) of the heart at rest and under drug- induced stress to receive data of the functional status of the heart and its perfusion as well as data of the pulmonary arterial perfusion.
Also obstruction of the pulmonary arteries will lead to reduced perfusion and cardiopulmonary exercise capacity.
Therefore the MRI data will be compared to cardiopulmonary exercise capacity data determined by cardio pulmonary stress test (CPX) concerning the feasibility of a correlation of the data and possible generalisation of the results leading to long term assessment of coronary perfusion and myocardial status after ASO for recommendations of physical activity of the young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •former EMAH (adults with congenital heart defects) patients > 18 years old
- •after neonatal ASO for TGA at the Department of pediatric cardiac surgery
- •also if applicable with a correction of an aorta isthmus stenosis neotal or in infancy
排除标准
- •contraindications of MRI as metallic implants, claustrophobia
- •contraindications of MRI contrast agents
- •severe chronic kidney disease (estimated glomerular filtration rate < 30 ml/min)
- •contraindications of exercise stress test with dobutamine or cardiopulmonary exercise stress test (e.g. instable angina pectoris, complex arrhythmia)
- •disabled persons not able to perform cardiopulmonary exercise stress test
- •pregnancy and breast feeding
结局指标
主要结局
Ejection Fraction (EF)
时间窗: up to 3 hours
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of the ejection fraction. Afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Heart rate (HR)
时间窗: up to 3 hours
MRI at rest will be performed, afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Wall motion
时间窗: up to 3 hours
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of wall motions. Induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
Pulmonary ventilation/pulmonary blood flow (V/Q in l/min)
时间窗: up to 3 hours
MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion. Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram/kg/min until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.
次要结局
- Breathing minute volume (VE l/min)(up to 1 hour)
- Peak oxygen uptake (VO2 in %)(up to 1 hour)
- Forced vital capacity (in %)(up to 1 hour)