Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
NCT ID: NCT04420468
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2020-06-10
2022-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Possible COVID-19 infection and acute myocarditis
Children presented with an acute myocarditis, fever and shock with a possible COVID-19 infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP Parisian hospitals :
* Necker-Enfants Malades
* Armand Trousseau
* Robert Debré
* Kremlin Bicêtre
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Admitted to PICU from April 2020
* Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection
Exclusion Criteria
* Other etiologies of acute myocarditis than the COVID-19
* Opposition expressed by the holders of parental authority
17 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Marion Grimaud
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Sylvain Renolleau, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Armand Trousseau
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
Hôpital Robert Debré
Paris, , France
Countries
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References
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McCafferty C, Cai T, Borgel D, Lasne D, Renolleau S, Vedrenne-Cloquet M, Bonnet D, Wu J, Zaw T, Bhatnagar A, Song X, Van Den Helm S, Letunica N, Attard C, Karlaftis V, Praporski S, Ignjatovic V, Monagle P. Pathophysiological pathway differences in children who present with COVID-19 ARDS compared to COVID -19 induced MIS-C. Nat Commun. 2022 May 2;13(1):2391. doi: 10.1038/s41467-022-29951-9.
Grimaud M, Starck J, Levy M, Marais C, Chareyre J, Khraiche D, Leruez-Ville M, Quartier P, Leger PL, Geslain G, Semaan N, Moulin F, Bendavid M, Jean S, Poncelet G, Renolleau S, Oualha M. Acute myocarditis and multisystem inflammatory emerging disease following SARS-CoV-2 infection in critically ill children. Ann Intensive Care. 2020 Jun 1;10(1):69. doi: 10.1186/s13613-020-00690-8.
Borgel D, Chocron R, Grimaud M, Philippe A, Chareyre J, Brakta C, Lasne D, Bonnet D, Toubiana J, Angoulvant F, Desvages M, Renolleau S, Smadja DM, Oualha M. Endothelial Dysfunction as a Component of Severe Acute Respiratory Syndrome Coronavirus 2-Related Multisystem Inflammatory Syndrome in Children With Shock. Crit Care Med. 2021 Nov 1;49(11):e1151-e1156. doi: 10.1097/CCM.0000000000005093.
Other Identifiers
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APHP200632
Identifier Type: -
Identifier Source: org_study_id
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