Multimodal Imaging Evaluation and Prognostic Analysis of Participants After Arterial Switch Operation

Arterial Switch Operation Clinical Trial

Official title:

Multimodal Imaging Evaluation and Prognostic Analysis of Participants With Transposition of the Great Arteries After Arterial Switch Operation: a Multi-site Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04980339
• Other study ID #: 2021 ASO V1.0
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: October 31, 2032

Study information

• Verified date: July 2022
• Source: Wuhan Union Hospital, China
• Contact: Li Zhang, PhD
• Phone: 18907131488
• Email: zli429[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2032
• Est. primary completion date: October 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

·Participants with the diagnosis of TGA or TBA underwent ASO.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arterial Switch Operation

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Xie Mingxing	Guangdong Provincial People's Hospital, Henan Provincial People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Wuhan Asia Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Number of participants with all cause mortality after ASO	Ten years
Secondary	Cardiac caused mortality	Number of participants with cardiac caused mortality after ASO	Ten years
Secondary	All cause reoperation	Number of participants with all cause reoperation after ASO	Ten years
Secondary	Right-ventricular outflow tract obstruction and pulmonary branch stenosis	Degree of more than moderate right-ventricular outflow tract obstruction in millimetre of mercury, degree of pulmonary branch stenosis in millimetre of mercury	Ten years
Secondary	Neoaortic valve regurgitation	Vena contracta width of neoaortic valve regurgitation in milimetre, ratio of Jet width/LVOT width in percentage	Ten years