Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 (COVID19) Cases (MYOCOVID)

Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 Cases During the Covid-19 Pandemic, Case Characteristics and Prognoses

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocarditis
• Intervention / Treatment: Diagnostic test: Performing routine care (clinical and paraclinical tests); Diagnostic test: Examinations for the research:

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.

• Study Type: Observational
• Enrollment (Actual): 756

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France
    • Cardiology
  • Amiens, France
    • Reanimation
  • Angers, France
    • Cardiology
  • Angers, France
    • Reanimation
  • Avignon, France
    • Cardiology
  • Bordeaux, France
    • Cardiology
  • Bordeaux, France
    • Pediatric Cardiology
  • Bordeaux, France
    • Reanimation
  • Brest, France
    • Cardiology
  • Caen, France
    • Cardiology
  • Caen, France
    • Pediatric Cardiology
  • Clermont-Ferrand, France
    • Cardiology
  • Clermont-Ferrand, France
    • Pediatric cardilogy
  • Clermont-Ferrand, France
    • Reanimation
  • Dijon, France
    • Pediatric Cardiology
  • Grenoble, France
    • Cardiology
  • Grenoble, France
    • Pediatric Cardiology
  • Grenoble, France
    • Reanimation
  • Lille, France
    • Cardiology
  • Lille, France
    • Pediatric Cardiology
  • Limoges, France
    • Pediatric Cardiology
  • Lyon, France
    • Cardiology
  • Lyon, France
    • Pediatric Cardiology
  • Marseille, France
    • Cardiology
  • Marseille, France
    • Pediatric Cardiology
  • Metz, France
    • Cardiology
  • Montpellier, France
    • Cardiology
  • Montpellier, France
    • Millénaire Clinical - Cardiology
  • Montpellier, France
    • Pediatric Cardiology
  • Montpellier, France
    • Reanimation
  • Nancy, France
    • Cardiology
  • Nancy, France
    • Pediatric Cardiology
  • Nantes, France
    • Cardiology
  • Nantes, France
    • Pediatric Cardiology
  • Nice, France
    • Cardiology
  • Nice, France
    • Pediatric Cardiology
  • Nîmes, France
    • Cardiology
  • Paris, France
    • Cardiology, Henri Mondor Hospital
  • Paris, France
    • Cardiology
  • Paris, France
    • Henri Mondor Hospital Reanimation
  • Paris, France
    • Marie Lannelongue Hospital - Pediatric Cardiology
  • Paris, France
    • Marie Lannelongue Hospital Cardiology
  • Paris, France
    • Reanimation
  • Paris, France
    • Robert Debré Hospital - Pediatric cardiology
  • Paris, France
    • Saint Antoine Hospital - Cardiology
  • Poitiers, France
    • Cardiology
  • Poitiers, France
    • Reanimation
  • Reims, France
    • Pediatric Cardiology
  • Rennes, France
    • Cardiology
  • Rennes, France
    • Pediatric reanimation
  • Rouen, France
    • Cardiology
  • Rouen, France
    • Pediatric Cardiology
  • Strasbourg, France
    • Pediatric Cardiology
  • Strasbourg, France
    • Reanimation
  • Toulouse, France, 31000
    • CHU de Toulouse
  • Toulouse, France
    • Croix du Sud Clinical
  • Toulouse, France
    • Pasteur Clinical - Cardiology
  • Toulouse, France
    • Pasteur Clinical - Pediatric cardiology
  • Toulouse, France
    • Pediatric Cardiology
  • Tours, France
    • Cardiolgy
  • Tours, France
    • Pediatric Cardiology
  • Valenciennes, France
    • Cardiology
• Martinique
  • Martinique, Martinique
    • Cardiology
• Mayotte
  • Mamoudzou, Mayotte
    • Cardiology
• Réunion
  • Réunion, Réunion
    • Pediatric Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in ICCU or ICU (polyvalent, surgical or medical), in one of the participating hospitals

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients treated for symptoms of acute myocarditis.; Patients treated in intensive coronary care unit (ICCU) or intensive care unit (ICU), 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.

Diagnostic test: Performing routine care (clinical and paraclinical tests); ECG, standard biology and cardiology tests, and routine transthoracic echocardiography (TTE), MRI; Diagnostic test: Examinations for the research: Systematic research by polymerase chain reaction (PCR) for Covid-19 in the blood and in an oro-pharyngeal swab, in addition to the usual immunologic, bacteriological, viral and parasitic tests carried out as part of the routine care of all patients with suspected myocarditis. A 30-days phone call follow-up (vital status) and a systematic 1-year follow-up will be realized (clinic, biology, ECG, TTE, +/- MRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the proportion of positive SARS-COV-2 cases.	Estimate at hospital discharge, over a period of 6 months, the evolution of the proportion of positive SARS-COV-2 cases among patients hospitalized for acute myocarditis in Intensive Cardiac Care Unit or Intensive Care Unit (polyvalent, surgical or medical), in the 19 hospitals participating in the study.	6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort; Echocardiographic parameters: Volumes (mm3)	1 year
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: diameters (mm)	1 year
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort (Echocardiographic parameters: ventricular diastolic function (mm);	1 year
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort (Echocardiographic parameters: ventricular systolic function (mm);	1 year
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Left atrium volume (mm3);	1 year
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Maximum velocity of tricuspid valve insufficiency;	1 year
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Presence and quantification of a valvular regurgitation	1 year
Ultrasound characteristics.	Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Presence of a pericardial effusion	1 year
Assess prognosis of the acute myocarditis .	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. The 30-day prognosis will be defined in function to the outcome: A death, whatever the cause, A cardiovascular arrest with recovery, A cardiogenic shock, An acute lung oedema or One of the events cited above. The 1-year prognosis will be defined in function to the outcome: A death, whatever the cause, The need to resort to transplantation and/or chronic assistance, A rehospitalization for cardiovascular reasons (heart failure, painful relapse, recovered cardiac arrest, myocarditis relapse, ACS), A myocarditis relapse, or one of the events cited above. The 1-year prognosis will also be defined in function to the New York Heart Association (NYHA) class.	The short-term (30 days) and long-term (1 year).
The factors associated with acute myocarditis cases .	Identify the factors associated with a 30-day and 1-year prognosis of cases of acute myocarditis cardiovascular (Terminal heart failure, Acute edema of the lung, Cardiogenic shock, Sudden death / Ventricular rhythm disorder Pulmonary embolism, Aortic dissection Infectious endocarditis Stroke) or no cardiovascular (Acute respiratory syndrome, septic shock of non-cardiac origin, cancer, Public road accident, end-stage respiratory failure, insufficiency, end-stage renal Failure)	The short-term (30 days) and long-term (1 year).
Biological characteristics	Describe the biological parameters on admission and during the treatment (troponinemia (ng/ml)	1 year
Biological characteristics	Describe the biological parameters on admission and during the treatment NtproBNP(pg/ml)	1 year
Biological characteristics	Describe the biological parameters on admission and during the treatment CRP(mg/ml)	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Ventricular volumes (ml)	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Systole Diameter	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Diastole Diameter	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Longitudinal deformation of left ventricle;	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Longitudinal deformation of right ventricle;	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Total volume of left ventricular oedema	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Quantification of T2 before contrast agent	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Quantification of T1 before contrast agent	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Perfusion anomalies	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Total volume of early left ventricular alteration	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Total volume of late left ventricular alteration	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Quantification of T1 after contrast agent	1 year
Describe at the admission and during the treatment cardiac MRI parameters	Presence of a pericardial effusion	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Clément Delmas, CHU Toulouse, Hôpital Rangueil

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Covid19; Prognosis; Epidemiology; Mortality; Myocarditis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Cardiomyopathies; COVID-19; Myocarditis
• Other Study ID Numbers: RC31/20/0139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No