Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases

Myocarditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05911386
• Other study ID #: 2023PI058
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2023

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: Aurelien Capogna
• Phone: +33603566308
• Email: a.capogna[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome
• Myocarditis
• Syndrome

Intervention

Other:
• study of biological samples and echocardiographic data and link with need of hemodynamic support
observational study : there is no intervention

Locations

Country	Name	City	State
France	Gilles BOSSER	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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