NCT05911386

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

May 9, 2023

Last Update Submit

August 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • deterioration of Left Ventricular Ejection fraction

    up to 20 days

Study Arms (3)

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

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

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

Interventions

observational study : there is no intervention

KAWASAKIMYOCARDITISPIMS

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilles BOSSER

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Myocarditispediatric multisystem inflammatory disease, COVID-19 relatedMucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVasculitisVascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of congenital and pediatric cardiology department

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 22, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations