Multimodal Imaging Evaluation and Prognostic Analysis of... | NCT04980339

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

NCT04980339

Sponsor

Xie Mingxing

Status

Not yet recruiting

Last Update Posted

Jul 13, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Arterial Switch Operation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Estimated

Primary Completion Date

Oct 31, 2032Estimated

Completion Date

Oct 31, 2032Estimated

First Submitted Date

Jul 10, 2021

First Submission Date that Met QC Criteria

Jul 26, 2021

First Posted Date

Jul 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2022

Last Update Posted Date

Jul 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xie Mingxing, Head of Department of Ultrasound, Union Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologySponsor-Investigator

Lead Sponsor

Xie MingxingOTHER

Collaborators

Name	Class
Second Affiliated Hospital, School of Medicine, Zhejiang University	OTHER
Shanghai Zhongshan Hospital	OTHER
Henan Provincial People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of this study are to

Identify the early and midterm outcomes in terms of mortality and reoperation of the arterial switch operation (ASO).
Identifying the influence of coronary artery anomalies on the in-hospital and post-discharge prognosis after ASO.
Evaluate the predictors for neoaortic valve regurgitation after ASO.
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:

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).
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.
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
ASO group		All participants with TGA/TBA after ASO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li Zhang, PhD	Contact	18907131488		zli429@hust.edu.cn

Overall Officials

Name	Affiliation	Role
Li Zhang, PhD	Department of Ultrasound, Union Hospital, Wuhan, China	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided