Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot
Multidetector Cardiac Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot in Pediatric
1 other identifier
observational
25
0 countries
N/A
Brief Summary
Evaluation of cardiac and extra cardiac vascular defects associated with Tetralogy of fallot in pediatric patients, regarding frequency and types of anomalies with assesment of multidetector computed tomography diagnostic value.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
December 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMarch 23, 2022
March 1, 2022
1 year
March 14, 2022
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of cardiac and extra cardiac vascular anomalies associated with tetralogy of Fallot by MDCT and its repercussion on preoperative decision.
The four main characteristics of TOF \[ventricular septal defect, overriding aorta, right ventricular outflow tract (RVOT) obstruction, and right ventricular hypertrophy\] and associated cardiac and extracardiac malformations will be analyzed and recorded using a sequential segmental approach. To compare the diagnostic performance of DSCT with that of TTE, we will categorize all the surgically confirmed associated cardiac and extracardiac vascular deformities into five groups, namely abnormal vena cava connection (AVCC), aortic artery and valve disorders, anomalies of the pulmonary artery and valve, deformities of the aortopulmonary vessels, and coronary artery anomalies (CAAs).
within a year
Eligibility Criteria
All preoperative TOF patients less than 18 years were included. All patients underwent MDCT and TTE preoperatively. All associated cardiac and extracardiac vascular abnormalities and their percentages will be recorded.
You may not qualify if:
- Non-surgical patients
- Patients with unstable clinical conditions
- Renal insufficiency
- Hypersensitivity to iodinated contrast.
- Age range of included patients:
- All pediatric patients less than 18 years were included. All patients underwent MDCT and TTE preoperatively. All associated cardiac and extracardiac vascular abnormalities and their percentages will be recorded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 23, 2022
Study Start
December 30, 2023
Primary Completion
December 30, 2024
Study Completion
December 30, 2025
Last Updated
March 23, 2022
Record last verified: 2022-03