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AzTrials

Congenital Heart DiseaseNCT06752187

Value of MRI in Congenital Heart Disease

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

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Congenital heart disease (CHD) is the most prevalent congenital anomaly and a major cause of infant morbidity and mortality. It encompasses various cardiac chamber anomalies. CHD diagnosis relied on clinical information from auscultation and heart sounds, with X-rays providing indirect information. Read more about this study

Who is it for?
Ages 0 to 18 years
Conditions the study is for
Congenital Heart Disease
How many people
55 participants
Where
No sites listed yet
Study dates
Jan 2025to Feb 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Child, Adult

Study population: The study population will include infants and children aged 0-18 years who are either suspected of having or diagnosed with congenital heart disease (CHD). Inclusion will require patients referred for magnetic resonance imaging (MRI) to further evaluate cardiac anatomy, function, or associated vascular anomalies.

Who may be able to join

  • Infants and children who diagnosed or suspected congenital heart diseases
  • Infants and children who can tolerate sedation or general anesthesia

Who cannot join

  • patients with contraindications to MRI as pacemaker or defibrillator
  • patients unable to tolerate sedation or anesthesia

About this study

Official title: Diagnostic Values of MRI in Congenital Heart Disease

Congenital heart disease (CHD) is the most prevalent congenital anomaly and a major cause of infant morbidity and mortality. It encompasses various cardiac chamber anomalies.

CHD diagnosis relied on clinical information from auscultation and heart sounds, with X-rays providing indirect information. Since the 1970s, echocardiography has become the primary diagnostic tool due to its direct, safe, and portable nature, capable of defining anatomy and estimating hemodynamics. However, echocardiography has limitations, While CT provides valuable anatomical details, it lacks hemodynamic information and involves ionizing radiation. MRI, on the other hand, excels in both anatomical and functional analysis, offering detailed hemodynamic evaluations of blood flow through valves, great vessels, and septal defects.

Read the detailed description

Congenital heart disease (CHD) is the most prevalent congenital anomaly and a major cause of infant morbidity and mortality. It encompasses various cardiac chamber anomalies such as septal defects, valvular lesions, and outflow tract anomalies. Advances in diagnostic tools, medical management, and surgical techniques have significantly improved survival rates, with over 90% of children with complex CHD living into adulthood. As of 2012, the prevalence of CHD was estimated at 3000 per million, and in the U.S., the number of adults with complex CHD increased from 110,000 in 1968 to 270,000 in 2010.

Historically, CHD diagnosis relied on clinical information from auscultation and heart sounds, with X-rays providing indirect information. Since the 1970s, echocardiography has become the primary diagnostic tool due to its direct, safe, and portable nature, capable of defining anatomy and estimating hemodynamics. However, echocardiography has limitations, including a restricted window of visualization.

Previously, CT and MRI faced challenges due to cardiac motion artifacts, but advancements in rapid imaging and high-resolution technology have improved their diagnostic capabilities. While CT provides valuable anatomical details, it lacks hemodynamic information and involves ionizing radiation. MRI, on the other hand, excels in both anatomical and functional analysis, offering detailed hemodynamic evaluations of blood flow through valves, great vessels, and septal defects.

Keywords
Congenital heart disease, MRI
Medical subject headings
Heart Defects, Congenital

What is being measured

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

  1. Evaluation of hemodynamics in congenital heart disease

    • The added value of MRI is evaluation of cardiac hemodynamics in congenital heart disease, and these hemodynamics include evaluation of the direction \& amount of blood flow through valves ,great vessels and septal defects.

    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 posted30 Dec 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionFeb 2026 (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
Other
Time perspective
Cross-sectional
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06752187
Sponsor's protocol ID
congenital heart disease MRI
Status last verified
Dec 2024
First submitted
21 Dec 2024
Last updated
30 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Muntean I, Toganel R, Benedek T. Genetics of Congenital Heart Disease: Past and Present. Biochem Genet. 2017 Apr;55(2):105-123. doi: 10.1007/s10528-016-9780-7. Epub 2016 Nov 2.

    PubMed 27807680

  • Fratz S, Chung T, Greil GF, Samyn MM, Taylor AM, Valsangiacomo Buechel ER, Yoo SJ, Powell AJ. Guidelines and protocols for cardiovascular magnetic resonance in children and adults with congenital heart disease: SCMR expert consensus group on congenital heart disease. J Cardiovasc Magn Reson. 2013 Jun 13;15(1):51. doi: 10.1186/1532-429X-15-51.

    PubMed 23763839

  • Renz DM, Bottcher J, Eckstein J, Huisinga C, Pfeil A, Lucke C, Gutberlet M. [Imaging of congenital heart defects with a focus on magnetic resonance imaging and computed tomography]. Radiologie (Heidelb). 2024 May;64(5):382-391. doi: 10.1007/s00117-024-01301-4. Epub 2024 Apr 24. German.

    PubMed 38656344

  • Ma P, Zhu L, Wen R, Lv F, Li Y, Li X, Zhang Z. Revolutionizing vascular imaging: trends and future directions of 4D flow MRI based on a 20-year bibliometric analysis. Quant Imaging Med Surg. 2024 Feb 1;14(2):1873-1890. doi: 10.21037/qims-23-1227. Epub 2024 Jan 18.

    PubMed 38415143

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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Dec 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of hemodynamics in 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 NCT06752187, which also lists 4 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 30 Dec 2024.

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