Multimodal Imaging Evaluation and Prognostic Analysis of Participants After Arterial Switch Operation
NCT ID: NCT04980339
Last Updated: 2022-07-13
Study Results
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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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2022-10-01
2032-10-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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COHORT
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
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Shanghai Zhongshan Hospital
OTHER
Henan Provincial People's Hospital
OTHER
Wuhan Asia Heart Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Xie Mingxing
OTHER
Responsible Party
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Xie Mingxing
Head of Department of Ultrasound, Union Hospital
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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Other Identifiers
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2021 ASO V1.0
Identifier Type: -
Identifier Source: org_study_id
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