Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-03-12 @ 3:02 AM
Study NCT ID:
NCT04420468
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2020-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEART-COVID
Brief Summary:
The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.
Detailed Description:
An unexpected increase of shock with fever in children suspected to be infect by the COVID-19 is observed. These children present with similar symptoms and seem to have similar clinical time course.
This unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual COVID-19 presentation in children.
The study consists an extensive retrospective data collection from April 2020 till the end of the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of Ile-de-France region.
The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.
This unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual COVID-19 presentation in children.
The study consists an extensive retrospective data collection from April 2020 till the end of the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of Ile-de-France region.
The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: