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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arterial Switch Operation

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All participants diagnosed with TGA or TBA underwent ASO in the hospital with an eligible cardiovascular surgery center.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ASO group; All participants with TGA/TBA after ASO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Number of participants with all cause mortality after ASO	Ten years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac caused mortality	Number of participants with cardiac caused mortality after ASO	Ten years
All cause reoperation	Number of participants with all cause reoperation after ASO	Ten years
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
Neoaortic valve regurgitation	Vena contracta width of neoaortic valve regurgitation in milimetre, ratio of Jet width/LVOT width in percentage	Ten years

Collaborators and Investigators

• Sponsor: Xie Mingxing
• Collaborators: Shanghai Zhongshan Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Guangdong Provincial People's Hospital; Henan Provincial People's Hospital; Wuhan Asia Heart Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 31, 2032
• Study Completion (Anticipated): October 31, 2032

Study Registration Dates

• First Submitted: July 10, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021 ASO V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No