The Role of Multislice Computed Tomography in Congenital Heart Diseases in Paediatric Age Group.

January 15, 2024 updated by: Mohamed Ahmed Abdelghany Elsherif, Sohag University
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag university hospitals- faculity of medicine

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

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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).

Description

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 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
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 )
within one week after Computed Tomography done

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

Magdi Yacoub Heart Foundation

Investigators

  • Principal Investigator: Mohamed AA Elsherif, ASSISST. LEC, Sohag university hospitals

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 (Actual)

January 3, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-12-02MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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