Arterial Switch OperationNCT04980339
Multimodal Imaging Evaluation and Prognostic Analysis of Participants After Arterial Switch Operation
An observational study of Arterial Switch Operation, run by Xie Mingxing.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arterial Switch Operation
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants diagnosed with TGA or TBA underwent ASO in the hospital with an eligible cardiovascular surgery center.
Who may be able to join
- ·Participants with the diagnosis of TGA or TBA underwent ASO.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Arterial Switch Operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASO group | All participants with TGA/TBA after ASO |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Number of participants with all cause mortality after ASO
Measured: Ten years
Secondary outcomes (4)
Cardiac caused mortality
Number of participants with cardiac caused mortality after ASO
Measured: Ten years
All cause reoperation
Number of participants with all cause reoperation after ASO
Measured: 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
Measured: Ten years
Neoaortic valve regurgitation
Vena contracta width of neoaortic valve regurgitation in milimetre, ratio of Jet width/LVOT width in percentage
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Oct 2022 (estimated)
- Primary completion31 Oct 2032 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Switch OperationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xie Mingxing
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Xie Mingxing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Li Zhang, PhD, Principal investigator, Department of Ultrasound, Union Hospital, Wuhan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980339
- Sponsor's protocol ID
- 2021 ASO V1.0
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04980339
- Acronym / sponsor ID
- 2021 ASO V1.0
- Conditions
- Arterial Switch Operation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xie MingxingUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASO group | – | –All participants with TGA/TBA after ASO |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants diagnosed with TGA or TBA underwent ASO in the hospital with an eligible cardiovascular surgery center.
Key inclusion criteria (1 listed)
- ·Participants with the diagnosis of TGA or TBA underwent ASO.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: Ten years
Number of participants with all cause mortality after ASO
4 secondary outcomes
Cardiac caused mortality
Time frame: Ten years
All cause reoperation
Time frame: Ten years
Right-ventricular outflow tract obstruction and pulmonary branch stenosis
Time frame: Ten years
Neoaortic valve regurgitation
Time frame: Ten years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Arterial Switch Operation
Active, not recruitingObservational study
Comprehensive Long-term Follow up of Adults With Arterial Switch Operation
Transposition of Great Vessels
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang, PhD principal investigator
Department of Ultrasound, Union Hospital, Wuhan, China
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Switch Operation, run by Xie Mingxing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, PhD (18907131488, zli429@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.