Comparison Between Multislice CT and Echocardiography in Diagnosis of Pediatric Congenital Heart Disease (CHD)

September 15, 2022 updated by: Mohamed Bahaa, Assiut University

Comparison Between Multislice CT 128 and Echocardiography in Diagnosis of Pediatric Congenital Heart Disease

  1. Assesment of pediatric CHD by Echocardiography and Multislice CT before operation and compare with surgical results.
  2. Compare echocardiogram and 128-Multislice spiral computed tomography(MSCT) in the diagnosis of pediatric CHD.
  3. Confirm echocardiographic finding in pediatric CHD by(MSCT) and to show the role of MSCT in diagnosing of extra-cardia anomalies.
  4. to show the role of MSCT as a useful tool in defintive diagnosis of congenital heart disease before operations which assist surgeons

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Congenital heart defect , also known as a congenital heart anomaly and congenital heart disease, is a defect in the structure of the heart or great vessels that is present at birth(1).

(congenital heart disease)(CHD), is the most frequent type of congenital birth deficiency disorder, with an incidence of 8% among newborns (2).

ECHO is the criterion standard and first-line diagnostic technique in diagnosing patients with CHD(11). For example, fetal echocardiography plays an important role in classifying the CHD in utero, allowing patients to be classified as having major, minor, or no CHD based on the echocardiographic results(3).

MSCT provides detailed, minimally invasive diagnosis and data on coronary artery anatomy in infants, children, and adults with CHD(13). CT,including CT angiography(CTA),is important in the evaluation of pediatric CHD.It can be used for accurate determination of complex cardiovascular anatomic features both before and after surgery and of a variety of post-treatment complications.

CT facilitate the assessment of extra-cardiac systemic and pulmonary arterial and venous structures(4).

Although the role of CT in the evaluation of pediatric congenital heart disease is being redefined and expanded, there are several generally accepted clinical indications for which the benefits of imaging outweigh the risks.First, CT can be used to evaluate patients with CHD known or suspected on the basis of echocardiographic findings for which further imaging is needed to characterize extra-cardiac anomalies before intervention.

The pulmonary arteries,pulmonary viens,and aortic arch and great vessels may be inadequately characterized at echocardiography, necessitating further assessment with CT (5).

History taking with emphasis on: age, gender, symptoms of heart failure as difficult breathing, palpitation, body swelling, and age of onset of these symptoms, as well as, syncopal attacks, cyanotic spills (blue color around lips), and failure to thrive.

2-Physical examination

  1. Anthropometric measurement as weight,height,head circumference.
  2. Vital signs as temperature,heart rate, respiratory rate,blood pressure.
  3. General examination for detection of cyanosis and signs of heart failure as lower limb edema, hepatomegaly.
  4. Cardiac examination for detection of pericardial bulge, dilated veins, abnormal pulsation,abnormal heart sounds and audible murmur.

3-Echocardiography ECHO will be performed using the Diamond Select iE33 Ultrasound system (Philips Medical Systems, Netherlands)(6). The procedures of the cardia acoustic window will be strictly followed. ECHO often will start with subcostal an acoustic window or subcostal acoustic window, and the major cardiovascular structures will be assessed according to Van Praagh segmental analysis(7).

4-128-MSCT Patients will be given oral chloral hydrate solution with a dosage of 50 mg/kg. The 64-MSCT examination will be performed by SOMATOM Perspective (Siemens, Germany)(8),with tube voltage of 80-100Kv, tube current of 80-100 mAs (vary during acquisition and according to the weight of the children), pitch of 1.2, and 0.6 mm collimation. A contrast medium dosage will be 1.2-2.0 mL/kg (Omnipaque 350 mg/mL), and will be followed by the same volume of saline chaser with an injection rate of 1-1.5 mL/s(9).

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

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

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children with congenital heart disease less than 18years

Description

Inclusion Criteria:

  • children with congenital heart disease less than 18years

Exclusion Criteria:

  • • Children with congenital heart disease >18 years.

    • Children suffering from renal disease .
    • Children with non-sinus rhythm .
    • Children who are allergic to iodinated contrast media .

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between Multislice CT and Echo cardiography in diagnosis of congenital heart disease
Time Frame: baseline

The study will be conducted at Assiut University Children Hospital from septemper 2022 to septemper 2023 on children with congenital heart disease

1-Echocardiography ECHO will be performed using the Diamond Select iE33 Ultrasound system (Philips Medical Systems, Netherlands)(6) 2-128-MSCT Patients will be given oral chloral hydrate solution with a dosage of 50 mg/kg. The 64-MSCT examination will be performed by SOMATOM Perspective
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 10, 2022

Primary Completion (Anticipated)

September 10, 2022

Study Completion (Anticipated)

November 10, 2022

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • comparison between CT and Echo

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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