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NCT Number: NCT06752187

Value 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of hemodynamics in congenital heart disease

    Time frame: Baseline

    • 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Diagnostic Values of MRI in Congenital Heart Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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