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Not yet recruitingNCT06752187Updated Dec 30, 2024

Value of MRI in Congenital Heart Disease

An observational study in Congenital Heart Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-30.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
55
Ages
0 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Congenital Heart Disease

Keywords

  • Congenital heart disease
  • MRI
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In context

Heart Defects, Congenital

1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.

This study's planned enrollment of 55 is below the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with contraindications to MRI as pacemaker or defibrillator
  • patients unable to tolerate sedation or anesthesia
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
55 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

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References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Jan 2026, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2024
First posted
Dec 30, 2024
StartEst.
Jan 2025
Primary completionEst.
Jan 2026
CompletionEst.
Feb 2026
Last update
Dec 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06752187
Lead sponsor
Assiut University
Responsible party
Aya Ezzat Abd el-aa (Principal investigator, Assiut University) — Principal investigator
First posted
Dec 30, 2024
Start date
Jan 2025 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Dec 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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