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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04787172
Other study ID # MSCT in congenital CVA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date September 1, 2022

Study information

Verified date March 2021
Source Assiut University
Contact Sara Ali Gamal, MD
Phone 01020230930
Email sararad423@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Congenital heart diseases (CHDs) are considered as the most common congenital birth defects, comprising 1% of all live births . Echocardiography remains a first-line non-invasive imaging tool for establishing the diagnosis and follow-up in most patients .This method is operator dependent and limited by an acoustic window . Traditional angiography is typically utilized as the gold standard modality for diagnosing CHD, but it is an invasive method and need general anseathsia with dose of radiation exposure .After recent developments in CT and MR technologies, cardiac catheterization is no longer necessary for diagnosis .


Description:

The interpretation of cardiovascular structures on cardiac CT scan studies is similar to that for echocardiography, however, it is not limited by the acoustic window or operator dependent like ultrasonography. In addition to the anatomic information, a cardiac CT scan provides hemodynamic information, including extracardiac and intra-cardiac shunts. It also enables the systematic evaluation of other thoracic structures like cardiovascular structures, the airways and the lungs by using maximum and minimum intensity projections to delineate the vascular and airway structures, respectively. Extra-cardiac great vessels can be evaluated along their length; thus augmenting the role of cardiac CT scans in children with congenital heart diseases .Inspite of the poorer temporal resolution of cardiac CTA compared to echocardiography, yet the combination of rapid acquisition time, increased anatomic coverage, high spatial resolution, multiplanar reformation and 3D capability combined with a flexible ECG synchronization have improved the image quality of cardiac CT scans and minimizing the patient risks. Multidetector computed tomography has greatly advanced the noninvasive diagnosis of these anomalies in pediatric patient, thus makes MDCT an ideal non- invasive method for evaluating pediatric patients .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients suffering from congenital cardiovascular diseases diagnosed either clinically or by echocardiographic examination. Exclusion Criteria: - orthopenic patient patients with hypersensitivity to contrast , medium and poor renal function .

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Multi Slice computed tomography
use of MSCT as a diagnostic tool in evaluation of patients with congenital cardiovascular anomalies

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Goitein O, Salem Y, Jacobson J, Goitein D, Mishali D, Hamdan A, Kuperstein R, Di Segni E, Konen E. The role of cardiac computed tomography in infants with congenital heart disease. Isr Med Assoc J. 2014 Mar;16(3):147-52. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy of the MSCT in congenital cardiovascular anomalies comparison between sensitivity and accuracy of MSCT in detection of congenital cardiovascular anomalies with detection rate by cardiac catheterization or surgery baseline