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临床试验/NCT06324903
NCT06324903尚未招募不适用

Role of Echocardiography in Optimization of Cardiac Catheterization Performance in Children With Congenital Heart Disease

Assiut University0 个研究点目标入组 67 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
67
主要终点
congenital heart defect dimensions in mm,

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • • 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.

结局指标

主要结局

congenital heart defect dimensions in mm,

时间窗: 2 DAYS

congenital heart defect dimensions in mm which are patent ductus arteriosus (PDA), ventricular septal defect (VSD), atrial septal defect (ASD) dimensions in (mm) millimeter. comparing pre-catheter and intra-catheter procedure measurement measuring by transthoracic echocardiography 24 hours pre-catheter then intra-catheter by transesophageal echocardiography and transcatheter angiography.

pressure gradient in mmHg across valve

时间窗: 2 DAYS

pressure gradient in mmHg which are valvular pulmonary stenosis (VPS) pressure gradient in mmHg. pulmonary hypertension measured in mmHg. comparing pre-catheter and intra-catheter procedure measurement measuring by transthoracic echocardiography 24 hours pre-catheter then intra-catheter by transesophageal echocardiography and transcatheter angiography.

次要结局

  • cardiac function by measuring fraction shortening (FS) % in percent(6 months)
  • cardiac function TAPSV in cm/sec(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Abdelmonem Abdelgalil Mohamed

principle investigator

Assiut University

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