Clinical trial NCT06752187: Value of MRI in Congenital Heart Disease
Official title: Diagnostic Values of MRI in Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congenital Heart Disease
Keywords: Congenital heart disease
MRI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 55
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of hemodynamics in congenital heart disease
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.