Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children (HEART-COVID)
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|ClinicalTrials.gov Identifier: NCT04420468|
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : May 24, 2021
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children|
|Actual Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
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 :
- Acute myocarditis [ Time Frame: 7 days ]Occurrence, description and time course of acute myocarditis
- Multi-systemic inflammatory syndrome [ Time Frame: 7 days ]Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease
- Kawasaki disease [ Time Frame: 7 days ]Occurrence, description and time course of features of Kawasaki disease
- Results of SARS-CoV-2 [ Time Frame: 7 days ]Results of SARS-CoV-2 screening either by PCR or antibodies serological assay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420468
|Contact: Marion Grimaud, MD||1 87 89 20 19 ext +firstname.lastname@example.org|
|Contact: Hélène Morel||1 71 19 63 46 ext +email@example.com|
|Le Kremlin-Bicêtre, France, 94270|
|Contact: Clémence Marais, MD firstname.lastname@example.org|
|Hôpital Armand Trousseau||Recruiting|
|Paris, France, 75012|
|Contact: Julie Starck, MD email@example.com|
|Hôpital Necker-Enfants Malades||Recruiting|
|Paris, France, 75015|
|Contact: Marion Grimaud, MD 1 87 89 20 19 ext +33 firstname.lastname@example.org|
|Hôpital Robert Debré||Recruiting|
|Paris, France, 75019|
|Contact: Michäel Levy, MD email@example.com|
|Principal Investigator:||Marion Grimaud||Assistance Publique - Hôpitaux de Paris|
|Study Director:||Sylvain Renolleau, MD, PhD||Assistance Publique - Hôpitaux de Paris|