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

NCT06324903 | Not Yet Recruiting

• 1 other identifier: echo cath CHD
• Study Type: observational
• Target: 67
• Locations: 0 countries
• Sites: N/A

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

Conditions

Echocardiography

Outcome Measures

Primary Outcomes (2)

• congenital heart defect dimensions in mm,

  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

  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 Outcomes (2)

• cardiac function by measuring fraction shortening (FS) % in percent

  6 months

• cardiac function TAPSV in cm/sec

  6 months

Interventions

echocardiography and percutaneous cardiac catheterization OTHER

pre- cardiac catheterization, intraprocedural and post-catheterization echocardiography.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (14)

• van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.

  PMID: 22078432 BACKGROUND

• Sachdeva R, Valente AM, Armstrong AK, Cook SC, Han BK, Lopez L, Lui GK, Pickard SS, Powell AJ, Bhave NM, Sachdeva R, Valente AM, Pickard SS, Baffa JM, Banka P, Cohen SB, Glickstein JS, Kanter JP, Kanter RJ, Kim YY, Kipps AK, Latson LA, Lin JP, Parra DA, Rodriguez FH 3rd, Saarel EV, Srivastava S, Stephenson EA, Stout KK, Zaidi AN. ACC/AHA/ASE/HRS/ISACHD/SCAI/SCCT/SCMR/SOPE 2020 Appropriate Use Criteria for Multimodality Imaging During the Follow-Up Care of Patients With Congenital Heart Disease: A Report of the American College of Cardiology Solution Set Oversight Committee and Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Pediatric Echocardiography. J Am Coll Cardiol. 2020 Feb 18;75(6):657-703. doi: 10.1016/j.jacc.2019.10.002. Epub 2020 Jan 6. No abstract available.

  PMID: 31918898 BACKGROUND

• Ramlawi B. The Era of Catheter-Based and Minimally Invasive Cardiac Surgery. Methodist Debakey Cardiovasc J. 2016 Jan-Mar;12(1):3. doi: 10.14797/mdcj-12-1-3. No abstract available.

  PMID: 27127554 BACKGROUND

• Turner ME, Bouhout I, Petit CJ, Kalfa D. Transcatheter Closure of Atrial and Ventricular Septal Defects: JACC Focus Seminar. J Am Coll Cardiol. 2022 Jun 7;79(22):2247-2258. doi: 10.1016/j.jacc.2021.08.082.

  PMID: 35654496 BACKGROUND

• Divekar AA, Arar YM, Clark S, Tandon A, Zellers TM, Veeram Reddy SR. Transcatheter Device Therapy and the Integration of Advanced Imaging in Congenital Heart Disease. Children (Basel). 2022 Apr 2;9(4):497. doi: 10.3390/children9040497.

  PMID: 35455541 BACKGROUND

• Avesani M, Kang SL, Jalal Z, Thambo JB, Iriart X. Renaissance of Cardiac Imaging to Assist Percutaneous Interventions in Congenital Heart Diseases:The Role of Three-Dimensional Echocardiography and Multimodality Imaging. Front Pediatr. 2022 May 19;10:894472. doi: 10.3389/fped.2022.894472. eCollection 2022.

  PMID: 35664875 BACKGROUND

• Kenny D. Interventional Cardiology for Congenital Heart Disease. Korean Circ J. 2018 May;48(5):350-364. doi: 10.4070/kcj.2018.0064. Epub 2018 Mar 29.

  PMID: 29671282 BACKGROUND

• Maragiannis D, Little SH. Interventional imaging: the role of echocardiography. Methodist Debakey Cardiovasc J. 2014 Jul-Sep;10(3):172-7. doi: 10.14797/mdcj-10-3-172.

  PMID: 25574345 BACKGROUND

• Zhang X, Gosnell J, Nainamalai V, Page S, Huang S, Haw M, Peng B, Vettukattil J, Jiang J. Advances in TEE-Centric Intraprocedural Multimodal Image Guidance for Congenital and Structural Heart Disease. Diagnostics (Basel). 2023 Sep 18;13(18):2981. doi: 10.3390/diagnostics13182981.

  PMID: 37761348 BACKGROUND

• Ludomirsky A. The use of echocardiography in pediatric interventional cardiac catheterization procedures. J Interv Cardiol. 1995 Oct;8(5):569-78. doi: 10.1111/j.1540-8183.1995.tb00584.x.

  PMID: 10159521 BACKGROUND

• Little SH, Rigolin VH, Garcia-Sayan E, Hahn RT, Hung J, Mackensen GB, Mankad S, Quader N, Saric M. Recommendations for Special Competency in Echocardiographic Guidance of Structural Heart Disease Interventions: From the American Society of Echocardiography. J Am Soc Echocardiogr. 2023 Apr;36(4):350-365. doi: 10.1016/j.echo.2023.01.014. Epub 2023 Feb 24.

  PMID: 36841670 BACKGROUND

• Broder MS, Gibbs SN, Yermilov I. An Adaptation of the RAND/UCLA Modified Delphi Panel Method in the Time of COVID-19. J Healthc Leadersh. 2022 May 20;14:63-70. doi: 10.2147/JHL.S352500. eCollection 2022.

  PMID: 35634010 BACKGROUND

• Sharma AK, Agarwal A, Sinha SK, Razi MM, Pandey U, Shukla P, Thakur R, Verma CM, Bansal RK, Krishna V. An echocardiographic evaluation to determine the immediate and short-term changes in biventricular systolic and diastolic functions after PDA device closure-an observational analytical prospective study (echo- PDA study). Indian Heart J. 2021 Sep-Oct;73(5):617-621. doi: 10.1016/j.ihj.2021.06.017. Epub 2021 Jul 6.

  PMID: 34627579 BACKGROUND

• Hou M, Qian W, Wang B, Zhou W, Zhang J, Ding Y, Xu Q, Huang J, Shen J, Cao L, Lv H, Sun L. Echocardiographic Prediction of Left Ventricular Dysfunction After Transcatheter Patent Ductus Arteriosus Closure in Children. Front Pediatr. 2019 Oct 15;7:409. doi: 10.3389/fped.2019.00409. eCollection 2019.

  PMID: 31681709 BACKGROUND

Central Study Contacts

Asmaa AA Mohamed

CONTACT

00201004493745; Asmaa.Abdelmonem@med.aun.edu.eg

Salah-Eldin Amry, Professor Dr

CONTACT

00201146082024; S_amry@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 30, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03