Congenital Heart DiseasesNCT06223321
The Role of Multislice Computed Tomography in Congenital Heart Diseases in Paediatric Age Group.
An observational study of Congenital Heart Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the added value of cardiac multislice Computed Tomography in assessment of CHD in pediatrics as a non-invasive presurgical planning method Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Diseases
- What is being tested?
- Computed Tomography in congenital heart diseases
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2023to Dec 2024
- 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 day to 18 years
- All sexes
- Child, Adult
Study population: * All children gave an informed consent prior performing the research. * Every child was submitted to full history taking. * Clinical assessment of the patients will be performed in the form of: measuring of vital signs and anthropometric measurements. * Renal function tests(ѕerum creatinine and blood urea).
Who may be able to join
- Patients suspected to have congenital heart disease based on clinical findings.
- Patients known to have congenital heart diseased based on echocardiography (ECHO) with ECHO findings are not sufficient and referred to perform CT for further assessment
Who cannot join
- Post-operative Patients of congenital heart disease.
- Patients who are known to have hyper susceptibility to iodinated Contrast media reaction, impaired renal functions, respiratory failure, fever and severe asthma and patients with arrhythmia.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the added value of cardiac multislice Computed Tomography in assessment of CHD in pediatrics as a non-invasive presurgical planning method
Read the detailed description
All patients will be subjected to the followings:
- All children gave an informed consent prior performing the research.
- Every child was submitted to full history taking.
- Clinical assessment of the patients will be performed in the form of: measuring of vital signs and anthropometric measurements.
- Renal function tests(ѕerum creatinine and blood urea).
- Patients will be prepared for CT as following:
- Calculation of amount of CM and sedations.
- The patient will be fasting for 4 hours.
- The peripheral venous line will placed usually in a right upper limb vein, exercise if cosurgical .
- The patients will be put in a supine position and at the middle of CT gantry.
- ECG leads will be put on the chest of the patient. Infants below 6 months will be laid with arms at their side or above their head for image acquisition, positioning the arms above their head is advised, while patients above 6 months of age were positioned with their arms above their head when possible.
- CT examination will be done by
- 160 MDCT Toshiba Machine or 128 MDCT GE machine or 160 MDCT Philips Machine:
- We used the following parameters during cardiac CT scanning:
- Pitch of 1.3, helical thickness of 0.5 mm and coverage of 32 cm.
- The radiation dose set to 80-100 kvp.
- Tube current from 10 to 40 mA/kg.
- The gantry rotation speed at 0.35-.4 sec.
- ECG gated Retrospective With MA modulation.
- Wide FOV.
- A scout will be taken and dual-phase injection conducted using non ionized contrast material. The total contrast volume is 1.5-3 ml/kg.
- Scanning begins when contrast filled the LV by bolus tracking.
- All images were transferred to workstation multiplanar reformation (MPR), maximum (MIP) and minimum (MinIP) intensity projections and volume rendering images will be performed for reporting.
- Reporting in sequential approach
- Cardiac sidedness
- Cardiac position
- Three segments , atrial chambers , ventricular chambers and the great arteries (aorta and pulmonary arteries)
- Cardiac connections (veno-atrial ,atrio-ventricular and ventriculo-arterial )
- Associated malformation (intra cardiac communications , valvular pathologies)
- Aortic arch and its branching pattern
- Pulmonary arteries
- Pulmonary veins (number and drainage pattern )
- SVC,IVC (their course and draining pattern )
- Systematic veins azygos , hemiazygos and brachiocephalic vein
- Coronary arteries
- Position of abdominal organs( liver spleen, stomach \& pancrease )
- Secondary changes in cardiac chambers and lung parenchyma
- Bony anomalies
- Results: Results will be tabulated and assessed statistically and compared to other published results.
- Ethical consideration and Study approval: The study protocol will be approved by the ethics committee of Faculty of Medicine, Sohag University.
- Conditions
- Congenital Heart Diseases
- Being tested
- Computed Tomography in congenital heart diseases
- Keywords
- Computed Tomography - congenital heart diseases
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography in congenital heart diseasesDiagnostic test
● CT examination will be done by
- 160 MDCT Toshiba Machine or 128 MDCT GE machine or 160 MDCT Philips Machine:
- We used the following parameters during cardiac CT scanning:
- Pitch of 1.3, helical thickness of 0.5 mm and coverage of 32 cm.
- The radiation dose set to 80-100 kvp.
- Tube current from 10 to 40 mA/kg.
- The gantry rotation speed at 0.35-.4 sec.
- ECG gated Retrospective With MA modulation.
- Wide FOV.
- A scout will be taken and dual-phase injection conducted using non ionized contrast material. The total contrast volume is 1.5-3 ml/kg.
- Scanning begins when contrast filled the LV by bolus tracking.
- All images were transferred to workstation multiplanar reformation (MPR), maximum (MIP) and minimum (MinIP) intensity projections and volume rendering images will be performed for reporting.
What is being measured
The primary outcome is the main question the study is designed to answer.
Multislice Computed Tomography in congenital heart diseases in Paediatric age group
added value of cardiac multislice Computed Tomography in assessment of CHD in pediatrics as a non-invasive presurgical planning method (detection of other lesion not seen by other imaging modalities )
Measured: within one week after Computed Tomography done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start3 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Magdi Yacoub Heart Foundation
- Responsible party
- Principal investigator, Mohamed Ahmed Abdelghany Elsherif, Sohag University
- Investigators
- Mohamed AA Elsherif, ASSISST. LEC, Principal investigator, Sohag University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223321
- Sponsor's protocol ID
- Soh-Med-23-12-02MD
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Multislice Computed Tomography in Congenital Heart Diseases in Paediatric Age Group.
- ClinicalTrials.gov ID
- NCT06223321
- Acronym / sponsor ID
- Soh-Med-23-12-02MD
- Conditions
- Congenital Heart Diseases
- Keywords
- Computed Tomography - congenital heart diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Magdi Yacoub Heart Foundation
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
This study aims to evaluate the added value of cardiac multislice Computed Tomography in assessment of CHD in pediatrics as a non-invasive presurgical planning method
Detailed description
All patients will be subjected to the followings:
- All children gave an informed consent prior performing the research.
- Every child was submitted to full history taking.
- Clinical assessment of the patients will be performed in the form of: measuring of vital signs and anthropometric measurements.
- Renal function tests(ѕerum creatinine and blood urea).
- Patients will be prepared for CT as following:
- Calculation of amount of CM and sedations.
- The patient will be fasting for 4 hours.
- The peripheral venous line will placed usually in a right upper limb vein, exercise if cosurgical .
- The patients will be put in a supine position and at the middle of CT gantry.
- ECG leads will be put on the chest of the patient. Infants below 6 months will be laid with arms at their side or above their head for image acquisition, positioning the arms above their head is advised, while patients above 6 months of age were positioned with their arms above their head when possible.
- CT examination will be done by
- 160 MDCT Toshiba Machine or 128 MDCT GE machine or 160 MDCT Philips Machine:
- We used the following parameters during cardiac CT scanning:
- Pitch of 1.3, helical thickness of 0.5 mm and coverage of 32 cm.
- The radiation dose set to 80-100 kvp.
- Tube current from 10 to 40 mA/kg.
- The gantry rotation speed at 0.35-.4 sec.
- ECG gated Retrospective With MA modulation.
- Wide FOV.
- A scout will be taken and dual-phase injection conducted using non ionized contrast material. The total contrast volume is 1.5-3 ml/kg.
- Scanning begins when contrast filled the LV by bolus tracking.
- All images were transferred to workstation multiplanar reformation (MPR), maximum (MIP) and minimum (MinIP) intensity projections and volume rendering images will be performed for reporting.
- Reporting in sequential approach
- Cardiac sidedness
- Cardiac position
- Three segments , atrial chambers , ventricular chambers and the great arteries (aorta and pulmonary arteries)
- Cardiac connections (veno-atrial ,atrio-ventricular and ventriculo-arterial )
- Associated malformation (intra cardiac communications , valvular pathologies)
- Aortic arch and its branching pattern
- Pulmonary arteries
- Pulmonary veins (number and drainage pattern )
- SVC,IVC (their course and draining pattern )
- Systematic veins azygos , hemiazygos and brachiocephalic vein
- Coronary arteries
- Position of abdominal organs( liver spleen, stomach \& pancrease )
- Secondary changes in cardiac chambers and lung parenchyma
- Bony anomalies
- Results: Results will be tabulated and assessed statistically and compared to other published results.
- Ethical consideration and Study approval: The study protocol will be approved by the ethics committee of Faculty of Medicine, Sohag University.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- * All children gave an informed consent prior performing the research. * Every child was submitted to full history taking. * Clinical assessment of the patients will be performed in the form of: measuring of vital signs and anthropometric measurements. * Renal function tests(ѕerum creatinine and blood urea).
Key inclusion criteria (2 listed)
- Patients suspected to have congenital heart disease based on clinical findings.
- Patients known to have congenital heart diseased based on echocardiography (ECHO) with ECHO findings are not sufficient and referred to perform CT for further assessment
Key exclusion criteria (2 listed)
- Post-operative Patients of congenital heart disease.
- Patients who are known to have hyper susceptibility to iodinated Contrast media reaction, impaired renal functions, respiratory failure, fever and severe asthma and patients with arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography in congenital heart diseases● CT examination will be done by * 160 MDCT Toshiba Machine or 128 MDCT GE machine or 160 MDCT Philips Machine: * We used the following parameters during cardiac CT scanning: * Pitch of 1.3, helical thickness of 0.5 mm and coverage of 32 cm. * The radiation dose set to 80-100 kvp. * Tube current from 10 to 40 mA/kg. * The gantry rotation speed at 0.35-.4 sec. * ECG gated Retrospective With MA modulation. * Wide FOV. * A scout will be taken and dual-phase injection conducted using non ionized contrast material. The total contrast volume is 1.5-3 ml/kg. * Scanning begins when contrast filled the LV by bolus tracking. * All images were transferred to workstation multiplanar reformation (MPR), maximum (MIP) and minimum (MinIP) intensity projections and volume rendering images will be performed for reporting. | Diagnostic test | – |
Primary outcome
Multislice Computed Tomography in congenital heart diseases in Paediatric age group
Time frame: within one week after Computed Tomography done
added value of cardiac multislice Computed Tomography in assessment of CHD in pediatrics as a non-invasive presurgical planning method (detection of other lesion not seen by other imaging modalities )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed AA Elsherif, ASSISST. LEC principal investigator
Sohag University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Diseases, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 2 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Multislice Computed Tomography in congenital heart diseases in Paediatric age group (time frame: within one week after Computed Tomography done). 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 25 Jan 2024.