Fallot TetralogyNCT05291858
Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot
An observational study of Fallot Tetralogy, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Fallot Tetralogy
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fallot Tetralogy
- Medical subject headings
- Tetralogy of Fallot
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start30 Dec 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallot TetralogyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Rashed Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291858
- Sponsor's protocol ID
- Computed tomography in CHD
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidetector Cardiac Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot in Pediatric
- ClinicalTrials.gov ID
- NCT05291858
- Acronym / sponsor ID
- Computed tomography in CHD
- Conditions
- Fallot Tetralogy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Mar 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Non-surgical patients
- Patients with unstable clinical conditions
- Renal insufficiency
- Hypersensitivity to iodinated contrast.
- 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.
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
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fallot Tetralogy, run by Assiut University.
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 0 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: status not confirmed, as of the sponsor's last update on 23 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 23 Mar 2022.