跳至主要内容
临床试验/NCT04980339
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

  1. Identify the early and midterm outcomes in terms of mortality and reoperation of the arterial switch operation (ASO).
  2. Identifying the influence of coronary artery anomalies on the in-hospital and post-discharge prognosis after ASO.
  3. Evaluate the predictors for neoaortic valve regurgitation after ASO.
  4. 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:

  1. 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).
  2. 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.
  3. 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.
  4. 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

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

发起方
Xie Mingxing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xie Mingxing

Head of Department of Ultrasound, Union Hospital

Wuhan Union Hospital, China

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