Clinical trial NCT04375748: Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 (COVID19) Cases
Official title: Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 Cases During the Covid-19 Pandemic, Case Characteristics and Prognoses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocarditis
Keywords: Covid19
Myocarditis
Epidemiology
Prognosis
Mortality
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 756
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in ICCU or ICU (polyvalent, surgical or medical), in one of the participating hospitals

Brief summary: To date, the effects of SARS-Cov-2 (Covid-19) on the myocardium and the role it plays in the evolution towards an acute myocarditis are badly understood. The current pandemic of this emerging virus is an opportunity to assess the proportion of acute myocarditis attributable to SARS-Cov-2(Covid-19) and to assess the clinical, biological and imaging presentations, by means of a national prospective multicentre hospital registry of cases of acute myocarditis.

Detailed description: Although research on the subject has only recently started developing, the links have already been described between SARS-Cov-2 infection, the severity of the clinical status, and the presence of risk factors or a history of cardiovascular disease (hypertension, diabetes, stroke, etc.). Additionally, depending on the series and definition used for cardiac injury (troponin elevation and/or natriuretic peptides), this concerns 7-29% of patients with a clear predominance in severe patients. The mechanisms behind these troponin elevations and cardiac injury are likely to be multiple and variable depending on clinical presentation,severity and patient history. A significant association was found between troponin elevation, and that of CRP and NtproBNP, suggesting an inflammatory part to this cardiac damage. As with other coronaviruses, SARS-Cov-2 infection can cause massive release of proinflammatory cytokines which can lead to inflammation of the vascular wall. This can be the cause of true instability or even rupture of plaque(type1 infarction) but can also be responsible for tissue hypoxia without rupture of plaque causing myocardial pain (infarction type 2). In addition, there may be areal myocardial inflammation causing acute myocarditis, secondary to the cytokine storm or direct damage to the myocardium by the virus itself. In case of acute coronary syndrome presentation, a coronary exploration should be realized to highlight or eliminate a type 1 infarction, but it is clearly difficult to distinguish between a type 2 suffering (no viral attack direct but suffering from hypotension or hypoxia for example) and inflammatory myocardial damage with or without direct viral myocardial damage (myocarditis). In the context of the viral pandemic at Covid19, although few data exist,it is legitimate to consider the possibility of true arrays of acute inflammatory myocarditis or by direct viral attack which could thus modify the natural history and the prognosis of patients, thus justifying a dedicated diagnosis and treatment. The primary objective was to assess the proportion of positive SARS-Cov-2 cases among the patients included (hospitalized for acute myocarditis). During the study period, this proportion will be assessed at regular intervals, for example every month, or more frequently if the number of patients included varies substantially from one week to another. This will make it possible to trace a development curve for the entire period of the pandemic.

The secondary objectives were (1) to describe the clinical, biological and imaging characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort; (2) to assess the short-term (30 days) and long-term (1 year) prognosis of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort and (3) to identify the factors associated with a 30-day and 1-year prognosis of cases of acute myocarditis.

Eligibility criteria: Inclusion Criteria:

* Patients treated in ICCU or ICU (polyvalent, surgical or medical), in one of the participating hospitals, for symptoms of acute myocarditis confirmed by a myocardial MRI and/or a CT scan and/or a myocardial biopsy. It seems important to include elderly patients who may be under guardianship or curatorship since these patients seem to present the most severe forms. Additionally, the populations most affected by viral myocarditis are generally adolescents and young adults,which justifies including them in the study too. Pregnant women are a population at potentially greater risk, particularly during the third trimester because of the neuro-hormonal changes inherent in pregnancy. This justifies trying to implement the investigator's knowledge through this observational study.

Exclusion Criteria:

* Refusal to participate.

Primary outcomes:
measure: Evolution of the proportion of positive SARS-COV-2 cases.
timeFrame: 6 months.
Secondary outcomes:
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Ultrasound characteristics.
timeFrame: 1 year
measure: Assess prognosis of the acute myocarditis .
timeFrame: The short-term (30 days) and long-term (1 year).
measure: The factors associated with acute myocarditis cases .
timeFrame: The short-term (30 days) and long-term (1 year).
measure: Biological characteristics
timeFrame: 1 year
measure: Biological characteristics
timeFrame: 1 year
measure: Biological characteristics
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
measure: Describe at the admission and during the treatment cardiac MRI parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Cardiology
city: Amiens
country: France
facility: Reanimation
city: Angers
country: France
facility: Cardiology
city: Angers
country: France
facility: Reanimation
city: Avignon
country: France
facility: Cardiology
city: Bordeaux
country: France
facility: Cardiology
city: Bordeaux
country: France
facility: Pediatric cardiology
city: Bordeaux
country: France
facility: Reanimation
city: Brest
country: France
facility: Cardiology
city: Caen
country: France
facility: Cardiology
city: Caen
country: France
facility: Pediatric Cardiology
city: Clermont-Ferrand
country: France
facility: Cardiology
city: Clermont-Ferrand
country: France
facility: Pediatric cardilogy
city: Clermont-Ferrand
country: France
facility: Reanimation
city: Dijon
country: France
facility: Pediatric cardiology
city: Grenoble
country: France
facility: Cardiology
city: Grenoble
country: France
facility: Pediatric cardiology
city: Grenoble
country: France
facility: Reanimation
city: Lille
country: France
facility: Cardiology
city: Lille
country: France
facility: Pediatric cardiology
city: Limoges
country: France
facility: Pediatric cardiology
city: Lyon
country: France
facility: Cardiology
city: Lyon
country: France
facility: Pediatric cardiology
city: Marseille
country: France
facility: Cardiology
city: Marseille
country: France
facility: Pediatric cardiology
city: Metz
country: France
facility: Cardiology
city: Montpellier
country: France
facility: Cardiology
city: Montpellier
country: France
facility: Millénaire Clinical - Cardiology
city: Montpellier
country: France
facility: Pediatric cardiology
city: Montpellier
country: France
facility: Reanimation
city: Nancy
country: France
facility: Cardiology
city: Nancy
country: France
facility: Pediatric cardiology
city: Nantes
country: France
facility: Cardiology
city: Nantes
country: France
facility: Pediatric cardiology
city: Nice
country: France
facility: Cardiology
city: Nice
country: France
facility: Pediatric cardiology
city: Nîmes
country: France
facility: Cardiology
city: Paris
country: France
facility: Cardiology, Henri Mondor Hospital
city: Paris
country: France
facility: Cardiology
city: Paris
country: France
facility: Henri Mondor Hospital Reanimation
city: Paris
country: France
facility: Marie Lannelongue Hospital - Pediatric Cardiology
city: Paris
country: France
facility: Marie Lannelongue Hospital Cardiology
city: Paris
country: France
facility: Reanimation
city: Paris
country: France
facility: Robert Debré Hospital - Pediatric cardiology
city: Paris
country: France
facility: Saint Antoine Hospital - Cardiology
city: Poitiers
country: France
facility: Cardiology
city: Poitiers
country: France
facility: Reanimation
city: Reims
country: France
facility: Pediatric cardiology
city: Rennes
country: France
facility: Cardiology
city: Rennes
country: France
facility: Pediatric reanimation
city: Rouen
country: France
facility: Cardiology
city: Rouen
country: France
facility: Pediatric cardiology
city: Strasbourg
country: France
facility: Pédiatric cardiology
city: Strasbourg
country: France
facility: Reanimation
city: Toulouse
country: France
facility: CHU de TOULOUSE
city: Toulouse
country: France
facility: Croix du Sud Clinical
city: Toulouse
country: France
facility: Pasteur Clinical - Cardiology
city: Toulouse
country: France
facility: Pasteur Clinical - Pediatric cardiology
city: Toulouse
country: France
facility: Pediatric Cardiology
city: Tours
country: France
facility: Cardiolgy
city: Tours
country: France
facility: Pediatric Cardiology
city: Valenciennes
country: France
facility: Cardiology
city: Martinique
country: Martinique
facility: Cardiology
city: Mamoudzou
country: Mayotte
facility: Cardiology
city: Réunion
country: Réunion
facility: Pédiatric cardiology
Study officials:
affiliation: CHU Toulouse, Hôpital Rangueil
name: Clément Delmas
role: PRINCIPAL_INVESTIGATOR
References: