Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases

Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases (Including Pediatric Inflammatory Multisystemic Syndromes Related to Covid 19, Kawasaki Disease and Myocarditis)

Acquired inflammatory or infectious cardiac diseases, in pediatrics, include Kawasaki disease, myocarditis, and Covid-19-related Pediatric Multisystemic Inflammatory Syndrome (PIMS).

These 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. Nevertheless their modalities of monitoring, management and evolution are different. The investigators wish to retrospectively analyze biological and echocardiographic data of Kawasaki disease, myocarditis, PIMS patients managed at Nancy Children Hospital from January 1, 2017 to June 31, 2023.

The primary objective of this study is to identify, for these 3 pathologies, the prognostic factors of initiation of inotropic support.

The secondary objective is to identify the prognostic factors of degradation of ventricular function.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocarditis; Kawasaki Disease; Pediatric Inflammatory Multisystem Syndrome
• Intervention / Treatment: Other: study of biological samples and echocardiographic data and link with need of hemodynamic support

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Aurelien Capogna; Phone Number: +33603566308; Email: a.capogna@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • Gilles BOSSER
    • Contact: Gilles BOSSER, PhD; Email: g.bosser@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

age < 18 years initial management and follow up in Nancy university children hospital center for PIMS Myocarditis and Kawasaki disease patients

Description

Inclusion Criteria:

• diagnostic of PIMS, myocarditis or kawasaki disease patients
• age < 18 years

Exclusion Criteria:

• uncertain diagnosis
• other complex heart disease
• management out of Nancy University children hospital center

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MYOCARDITIS; No intervention Study of available clinical, biological, and echocardiographic data	Other: study of biological samples and echocardiographic data and link with need of hemodynamic support; observational study : there is no intervention
KAWASAKI; No intervention Study of available clinical, biological, and echocardiographic data	Other: study of biological samples and echocardiographic data and link with need of hemodynamic support; observational study : there is no intervention
PIMS; No intervention Study of available clinical, biological, and echocardiographic data	Other: study of biological samples and echocardiographic data and link with need of hemodynamic support; observational study : there is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need of hemodynamic support	The need for haemodynamic support is defined dichotomously: yes or no. The investigators wish to identify the predictive factors of need for haemodynamic support among the following variables: groups (PIMS, KAWASAKI, MYOCARDITIS), cardiac biomarkers (troponin and NT-pro-BNP at admission (in ng/ml)) and echocardiographic criterias (Left Ventricular Ejection fraction, global and regional longitudinal strain at admission (in %)).	up to 20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
deterioration of Left Ventricular Ejection fraction	Left Ventricular Ejection fraction degradation is defined as an Left Ventricular Ejection fraction below the value of the first quartile of Left Ventricular Ejection fraction of all patients taken into account (Left Ventricular Ejection fraction as a percentage). The investigators wish to identify the predictive factors of Left Ventricular Ejection fraction degradation among the following variables: groups (PIMS, KAWASAKI, MYOCARDITIS), cardiac biomarkers (troponin and NT-pro-BNP at admission (in ng/ml)) and echocardiographic criterias (Left Ventricular Ejection fraction , global and regional longitudinal strain at admission (in %)).	up to 20 days

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Disease; Vasculitis; Skin Diseases, Vascular; Cardiomyopathies; Heart Diseases; Syndrome; Myocarditis; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: 2023PI058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No