Clinical trial NCT06324903: Role of Echocardiography in Optimization of Cardiac Catheterization in Children With Congenital Heart Disease
Official title: Role of Echocardiography in Optimization of Cardiac Catheterization Performance in Children With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Echocardiography
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 67
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children age from 1 month to 18 years old. Hospitalized patients in pediatric cardiology unit, Assiut University Hospitals, who are prepared for cardiac catheterization.

Brief summary: Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals.

1. To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints.
2. To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow.
3. To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology.
4. To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications.

Detailed description: Congenital heart disease is estimated to affect approximately 1% of live births, underscoring the profound impact of this set of cardiac malformations . Echocardiography serves as the cornerstone imaging modality utilized in all aspects of care in this patient population - from initial diagnosis, to informing surgical and transcatheter interventions, to longitudinal surveillance . Recent decades have witnessed major advancements in the catheter-based treatment of Congenital heart disease , sparing patients from more invasive open-heart procedures in select cases . Transcatheter closure of defects such as atrial septal defects , ventricular septal defects and patent ductus arteriosus have become mainstream interventions . However, the complexity of Congenital heart disease anatomy necessitates meticulous procedural planning and guidance to achieve optimal outcomes following these catheterizations .

Importance of Standardized Echocardiography Protocols Echocardiography is invaluable before, during and after transcatheter interventions in patients with congenital heart disease. Precise delineation of anatomy facilitates appropriate procedure selection and planning - including choice of access, devices, and imaging guidance . Intraprocedural transesophageal echocardiography offers real-time visualization for device positioning and deployment as well as identification of complications . Post-intervention surveillance detects residual lesions, enables assessment of ventricular function and valvular regurgitation, and monitors for complications such as thrombosis or device erosion .

Despite extensive guidelines on the echocardiographic assessment of congenital heart disease, substantial inter-institutional variability persists in imaging for catheter-based procedures . Standardized protocols have demonstrated improvements in accuracy, consistency, and quality . However, adoption of such protocols is lagging. This gap highlights the pressing need for evidence-based protocols to optimize echocardiography practices.

This proposed protocol focuses on pre-catheterization, intraprocedural and post-catheterization transthoracic echocardiography and transesophageal echocardiography for common interventions - atrial septal defects closure, ventricular septal defects closure and patent ductus arteriosus closure. It provides comprehensive recommendations on essential views, measurements, and documentation. The protocol allows modularity to adapt components across different interventions. Wider adoption has the potential to substantially improve consistency, accuracy, patient safety and quality. Further studies are imperative to demonstrate the impact of implementing such standardized protocols. This initiative represents an important step towards advancing care for pediatric catheterizations.

Eligibility criteria: Inclusion Criteria:

* All infants and children from 1month to 18 years old with congenital cardiac defects indicated for cardiac catheterization

Exclusion Criteria:

* • Patients with complex cardiac disease,

  * Patients with a history of renal disease,
  * Patient who are less than 1 month,
  * Parental refusal to participate in the research.

Primary outcomes:
measure: congenital heart defect dimensions in mm,
timeFrame: 2 DAYS
measure: pressure gradient in mmHg across valve
timeFrame: 2 DAYS
Secondary outcomes:
measure: cardiac function by measuring fraction shortening (FS) % in percent
timeFrame: 6 months
measure: cardiac function TAPSV in cm/sec
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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