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

NCT ID: NCT04980339

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2032-10-31

Brief Summary

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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

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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.

Conditions

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Arterial Switch Operation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ASO group

All participants with TGA/TBA after ASO

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Xie Mingxing

OTHER

Sponsor Role lead

Responsible Party

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Xie Mingxing

Head of Department of Ultrasound, Union Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ultrasound, Union Hospital, Wuhan, China

Central Contacts

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Li Zhang, PhD

Role: CONTACT

18907131488

Other Identifiers

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2021 ASO V1.0

Identifier Type: -

Identifier Source: org_study_id

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