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Congenital Heart DiseaseCHDNCT05546008

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

An observational study of Congenital Heart Disease, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 0 to 18 years
Conditions the study is for
Congenital Heart Disease
What is being tested?
Multislice CT
Type of treatment
Medical device
How many people
150 participants
Where
No sites listed yet
Study dates
10 Sep 2022to 10 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • Child, Adult

Study population: children with congenital heart disease less than 18years

Who may be able to join

  • children with congenital heart disease less than 18years

Who cannot join

  • • 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 .

Trial locations and contacts

No sites are listed yet.

mohamed bahaa contact

01095444351

bahaamohmed054@gmail.com

Doaa Raafat contact

0107934347

Doaa-rafat2010@gmail.com

About this study

Official title: 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
Read the 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).

Being tested
Multislice CT
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multislice CTDevice

    Also called Echocardiography

    all patient will be subjected to echocardigraphy and multislice ct and compare thier results

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. comparison between Multislice CT and Echo cardiography in diagnosis of congenital heart disease

    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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start10 Sep 2022 (estimated)
  3. Primary completion10 Sep 2022 (estimated)
  4. Study completion10 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546008
Sponsor's protocol ID
comparison between CT and Echo
Acronym
CHD
Status last verified
Sep 2022
First submitted
15 Sep 2022
Last updated
19 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • VANPRAAGH R, VANPRAAGH S, VLAD P, KEITH JD. ANATOMIC TYPES OF CONGENITAL DEXTROCARDIA: DIAGNOSTIC AND EMBRYOLOGIC IMPLICATIONS. Am J Cardiol. 1964 Apr;13:510-31. doi: 10.1016/0002-9149(64)90159-6. No abstract available.

    PubMed 14136294

  • Alakhfash AA, Tamimi OR, Al-Khattabi AM, Najm HK. Treatment options for transposition of the great arteries with ventricular septal defect complicated by pulmonary vascular obstructive disease. J Saudi Heart Assoc. 2009 Jul;21(3):187-90. doi: 10.1016/j.jsha.2009.06.008. Epub 2009 Aug 5.

    PubMed 23960571

  • Pasquini L, Sanders SP, Parness I, Colan S, Keane JF, Mayer JE Jr, Kratz C, Foran RB, Marino B, Van Praagh S, et al. Echocardiographic and anatomic findings in atrioventricular discordance with ventriculoarterial concordance. Am J Cardiol. 1988 Dec 1;62(17):1256-62. doi: 10.1016/0002-9149(88)90270-6.

    PubMed 3195487

  • Wang XM, Wu LB, Sun C, Liu C, Chao BT, Han B, Zhang YT, Chen HS, Li ZJ. Clinical application of 64-slice spiral CT in the diagnosis of the Tetralogy of Fallot. Eur J Radiol. 2007 Nov;64(2):296-301. doi: 10.1016/j.ejrad.2007.02.026. Epub 2007 Mar 30.

    PubMed 17399932

  • Liu H, Juan YH, Chen J, Xie Z, Wang Q, Zhang X, Liang C, Huang H, Kwong RY, Saboo SS. Anomalous Origin of One Pulmonary Artery Branch From the Aorta: Role of MDCT Angiography. AJR Am J Roentgenol. 2015 May;204(5):979-87. doi: 10.2214/AJR.14.12730.

    PubMed 25905931

  • Watts JR Jr, Sonavane SK, Nath PH, Singh SP. Pictorial review of the role of multidetector computed tomography imaging in the postoperative evaluation of congenital heart disease. Curr Probl Diagn Radiol. 2014 Jul-Aug;43(4):205-18. doi: 10.1067/j.cpradiol.2014.04.001.

    PubMed 24948213

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Heart Disease, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mohamed bahaa (01095444351, bahaamohmed054@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison between Multislice CT and Echo cardiography in diagnosis of congenital heart disease (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05546008, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.

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