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

March 15, 2024 updated by: Asmaa Abdelmonem Abdelgalil Mohamed, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Salah-Eldin Amry, Professor Dr
  • Phone Number: 00201146082024
  • Email: S_amry@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
congenital heart defect dimensions in mm,
Time Frame: 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.
2 DAYS
pressure gradient in mmHg across valve
Time Frame: 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.
2 DAYS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac function by measuring fraction shortening (FS) % in percent
Time Frame: 6 months
echocardiography measurements of cardiac systolic function for 24 hours pre-catheterization studies, for 48 hours post-catheterization studies and on 6 months follow up ( LVEDD in mm, LVESD in mm, , FS in % ( Fractional shortening (FS) = LVEDD-LVESD/LVESD ×100 )
6 months
cardiac function TAPSV in cm/sec
Time Frame: 6 months
cardiac function of right side of the heart TAPSV in cm/sec, echocardiography tissue doppler measurements of cardiac systolic function for 24 hours pre-catheterization studies, for 48 hours post-catheterization studies and on 6 months follow up TAPSV in cm/sec.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • echo cath CHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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