NCT04980339尚未招募不适用
Multimodal Imaging Evaluation and Prognostic Analysis of Participants With Transposition of the Great Arteries After Arterial Switch Operation: a Multi-site Clinical Study
Xie Mingxing0 个研究点目标入组 1,000 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- All cause mortality
研究概览
简要总结
The aims of this study are to
- Identify the early and midterm outcomes in terms of mortality and reoperation of the arterial switch operation (ASO).
- Identifying the influence of coronary artery anomalies on the in-hospital and post-discharge prognosis after ASO.
- Evaluate the predictors for neoaortic valve regurgitation after ASO.
- Explore the risk factors for neopulmonary artery stenosis after ASO.
详细描述
This study will enroll participants with transposition of the great arteries (TGA) and double outlet right ventricle with subpulmonary ventricular septal defect (VSD) (Taussig-Bing anomaly, TBA). The cardiac structure and function will be evaluated by multimodal imaging including transthoracic echocardiographic examination, stress echocardiography, cardiac computed tomography scan, cardiovascular magnetic resonance imaging.
And the study aimed to:
- Identify the early and midterm outcomes in terms of mortality and reoperation of the arterial switch operation (ASO) in participants with transposition of the great arteries (TGA) and double outlet right ventricle with subpulmonary ventricular septal defect (VSD) (Taussig-Bing anomaly, TBA).
- Identifying subclinical coronary abnormalities and silent myocardial ischemia by multimodel Imaging, further determine the influence of coronary artery anomalies on the in-hospital and post-discharge prognosis in participants with TGA and TBA after ASO.
- Evaluate the time course and predictors for neoaortic root dilatation and neoaortic valve regurgitation in participants with TGA and TBA after ASO by multimodel Imaging.
- Assess the structure of the right ventricular outflow tract and neopulmonary artery in participants with TGA and TBA after ASO by multimodel Imaging, and explore the incidence and risk factors for neopulmonary artery stenosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •·Participants with the diagnosis of TGA or TBA underwent ASO.
排除标准
- •Patients with various forms of TGA undergoing Réparation à l'Etage Ventriculaire procedure
- •Patients with various forms of TGA undergoing Rastelli procedure
- •Patients with various forms of TGA undergoing Nikaidoh procedure
- •Patients with various forms of TGA undergoing Fontan operation
- •Patients with various forms of TGA undergoing atrial repair (Mustard or Senning) operations
- •ASO is used as a corrective therapy for prior operations.
结局指标
主要结局
All cause mortality
时间窗: Ten years
Number of participants with all cause mortality after ASO
次要结局
- Cardiac caused mortality(Ten years)
- All cause reoperation(Ten years)
- Right-ventricular outflow tract obstruction and pulmonary branch stenosis(Ten years)
- Neoaortic valve regurgitation(Ten years)
研究者
Xie Mingxing
Head of Department of Ultrasound, Union Hospital
Wuhan Union Hospital, China
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