- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05291858
Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot
March 14, 2022 updated by: Mariam Rashed Fahmy, Assiut University
Multidetector Cardiac Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot in Pediatric
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.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
25
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Exclusion criteria
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of cardiac and extra cardiac vascular anomalies associated with tetralogy of Fallot by MDCT and its repercussion on preoperative decision.
Time Frame: within a year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 30, 2023
Primary Completion (Anticipated)
December 30, 2024
Study Completion (Anticipated)
December 30, 2025
Study Registration Dates
First Submitted
March 14, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (Actual)
March 23, 2022
Study Record Updates
Last Update Posted (Actual)
March 23, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Computed tomography in CHD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fallot Tetralogy
-
Shanghai Jiao Tong University School of MedicineCompletedCongenital Heart Defects | Tetralogy Of FallotChina
-
Ain Shams UniversityRecruiting
-
University of California, San FranciscoCompletedPulmonary Regurgitation After Repair of Tetralogy of FallotUnited States
-
Indonesia UniversityCompletedMyocardial Injury | Cardiac SurgeryIndonesia
-
Hospital Universitari Vall d'Hebron Research InstituteRecruitingCongenital Heart Disease | Congenital Heart Defect | Fallot TetralogySpain
-
Assiut UniversityUnknown
-
Paris Cardiovascular Research Center (Inserm U970)European Georges Pompidou Hospital; Centre Chirurgical Marie Lannelongue; Hôpital... and other collaboratorsRecruitingCongenital Heart Disease | Ventricular Arrythmia | Pulmonary Valve Regurgitation | Fallot TetralogyFrance
-
Assistance Publique Hopitaux De MarseilleCompletedTetralogy of Fallot With Pulmonary StenosisFrance
-
Nationwide Children's HospitalCompletedTetralogy of Fallot (TOF) | Ventricular Septal Defects (VSD) | Atrioventricular Septal Defects (AVSD)United States
-
Aditya KazaNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingComplete Atrioventricular Canal | Ventricular Septal Defect | Tetralogy of Fallot With Pulmonary StenosisUnited States