An observational study in Fallot Tetralogy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Assiut University · Observational
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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.
Tetralogy of Fallot (TOF) is the most common complex cyanotic congenital heart disease (CHD), with a prevalence of 3.5-9%. Almost all pediatric patients born with TOF can now expect to survive to adulthood because of advances in its surgical treatment. In addition to the four diagnostic criteria of TOF that include ventricular septal defect, right ventricular hypertrophy with outflow tract obstruction, and overriding aorta, other extra-cardiac vascular anomalies are frequently coexist . These may involve pulmonary, aortic, and coronary arteries with or without valve abnormalities, aorto-pulmonary vessels, and vena cava connections, is crucial for surgeons in the formulation of surgical strategies. Trans-thoracic echocardiography (TTE) is the initial classical procedure done for these patients, as it can demonstrate heart structure and estimate intra-cardiac pressures, gradients, and contractile functions as well as blood flow direction across any heart defect and emphasizing coronary vessels integrity. However, many extracardiac vascular defects associated with different heart diseases cannot be detected accurately by TTE; consequently, heart catheterization with its invasive complications was widely used for confirming these abnormalities before surgery. Recently, the evolution of multi-slice or multi-detector computed tomography (MDCT) with its multi-planar information, lower doses of radiation, short scanning time, and easy availability suggested it to be a non-invasive reliable diagnostic method for detection of different malformations in pediatric patients with complex CHD. Thus, effective imaging modalities are required to provide a thorough preoperative anatomic description of the associated extracardiac vascular anomalies in pediatric patients with TOF in order to improve surgical planning and outcomes. In recent years, multi-detector computed tomography (MDCT) has become regarded as a reliable non-invasive tool for delineating various anomalies in patients with complex CHD. Few studies have focused on the preoperative evaluation of associated cardiac and extracardiac vascular anomalies in pediatric patients with TOF using MDCT, especially not large case series studies. In this study, we aim to investigate the diagnostic performance of MDCT for assessing associated cardiac and extracardiac vascular abnormalities in patients with TOF.
92 studies on the registry are indexed under Tetralogy of Fallot; 25 are open to participants now.
This study's planned enrollment of 25 is below the median of 150 across 40 observational studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Exclusion criteria
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: within a year
No study locations are listed for this record.
Start is estimated for Dec 2023; primary completion for Dec 2024, 12 months later.
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This study is not yet recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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