NCT05911386|Unknown
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Sponsor study identifier
observational
100
1 country
1
Study Start
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2023
Actual (reported)June 22, 2023
Actual (reported)September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
deterioration of Left Ventricular Ejection fraction
up to 20 days
No intervention Study of available clinical, biological, and echocardiographic data
No intervention Study of available clinical, biological, and echocardiographic data
No intervention Study of available clinical, biological, and echocardiographic data
observational study : there is no intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
age \< 18 years initial management and follow up in Nancy university children hospital center for PIMS Myocarditis and Kawasaki disease patients
Gilles BOSSER
Vandœuvre-lès-Nancy, 54511, France
First Submitted
May 9, 2023
First Posted
June 22, 2023
Study Start
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
September 2023
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 30, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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