Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06223321
Other study ID # Soh-Med-23-12-02MD
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 3, 2023
Est. completion date December 2024

Study information

Verified date January 2024
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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(Ń•erum 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers
Gender All
Age group 1 Day to 18 Years
Eligibility Inclusion Criteria: 1. Patients suspected to have congenital heart disease based on clinical findings. 2. 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 Exclusion Criteria: - 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.

Study Design


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
Egypt Sohag university hospitals- faculity of medicine Sohag

Sponsors (2)

Lead Sponsor Collaborator
Sohag University Magdi Yacoub Heart Foundation

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 ) within one week after Computed Tomography done
See also
  Status Clinical Trial Phase
Unknown status NCT01450956 - The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery N/A
Recruiting NCT02503267 - "Incidence and Consequences of Disorders of Glycosylation in Patients With Conotruncal and Septal Heart Defects" N/A
Terminated NCT03437148 - Non-Invasive Shunt Quantification in Interatrial Communication N/A
Completed NCT03005626 - Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases N/A
Completed NCT01619982 - Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients Phase 4
Recruiting NCT02542683 - Physical Activity and Cognitive Development in Children
Enrolling by invitation NCT02527811 - Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery Phase 4