Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05911386
Collaborator
(none)
100
1
3
33.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: study of biological samples and echocardiographic data and link with need of hemodynamic support

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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)
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. need of hemodynamic support [up to 20 days]

    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 (LVEF , global and regional longitudinal strain at admission (in %)).

Secondary Outcome Measures

  1. deterioration of LVEF [up to 20 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gilles BOSSER Vandœuvre-lès-Nancy France 54511

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BOSSER Gilles, chief of congenital and pediatric cardiology department, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05911386
Other Study ID Numbers:
  • 2023PI058
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023