Clinical trial NCT04980339: Multimodal Imaging Evaluation and Prognostic Analysis of Participants After Arterial Switch Operation
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arterial Switch Operation
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Shanghai Zhongshan Hospital
name: Henan Provincial People's Hospital
name: Wuhan Asia Heart Hospital
name: Guangdong Provincial People's Hospital
First posted: 2021-07-28
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants diagnosed with TGA or TBA underwent ASO in the hospital with an eligible cardiovascular surgery center.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All cause mortality
timeFrame: Ten years
Secondary outcomes:
measure: Cardiac caused mortality
timeFrame: Ten years
measure: All cause reoperation
timeFrame: Ten years
measure: Right-ventricular outflow tract obstruction and pulmonary branch stenosis
timeFrame: Ten years
measure: Neoaortic valve regurgitation
timeFrame: Ten years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ultrasound, Union Hospital, Wuhan, China
name: Li Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: