NCT06223321

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 2, 2024

Last Update Submit

January 15, 2024

Conditions

Keywords

Computed Tomography - congenital heart diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

● 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.

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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).

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospitals- faculity of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Mohamed AA Elsherif, ASSISST. LEC

    Sohag University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT LECTURE AT DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY DEPARTMENT

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 25, 2024

Study Start

January 3, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations