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NCT Number: NCT04375748

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

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.

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Key information

Conditions

Acute Myocarditis COVID-19 Cardiomyopathies Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Diseases Infections Lung Diseases Myocarditis Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology, Aix-en-Provence, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Performing routine care (clinical and paraclinical tests)

Diagnostic Test

ECG, standard biology and cardiology tests, and routine transthoracic echocardiography (TTE), MRI

Examinations for the research:

Diagnostic Test

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)

Primary outcomes

  1. Evolution of the proportion of positive SARS-COV-2 cases.

    Time frame: 6 months.

    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.

Secondary outcomes

  1. Ultrasound characteristics.

    Time frame: 1 year

    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)

  2. Ultrasound characteristics.

    Time frame: 1 year

    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)

  3. Ultrasound characteristics.

    Time frame: 1 year

    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);

  4. Ultrasound characteristics.

    Time frame: 1 year

    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);

  5. Ultrasound characteristics.

    Time frame: 1 year

    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);

  6. Ultrasound characteristics.

    Time frame: 1 year

    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;

  7. Ultrasound characteristics.

    Time frame: 1 year

    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

  8. Ultrasound characteristics.

    Time frame: 1 year

    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

  9. Assess prognosis of the acute myocarditis .

    Time frame: The short-term (30 days) and long-term (1 year).

    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.

  10. The factors associated with acute myocarditis cases .

    Time frame: The short-term (30 days) and long-term (1 year).

    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)

  11. Biological characteristics

    Time frame: 1 year

    Describe the biological parameters on admission and during the treatment (troponinemia (ng/ml)

  12. Biological characteristics

    Time frame: 1 year

    Describe the biological parameters on admission and during the treatment NtproBNP(pg/ml)

  13. Biological characteristics

    Time frame: 1 year

    Describe the biological parameters on admission and during the treatment CRP(mg/ml)

  14. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Ventricular volumes (ml)

  15. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Systole Diameter

  16. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Diastole Diameter

  17. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Longitudinal deformation of left ventricle;

  18. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Longitudinal deformation of right ventricle;

  19. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Total volume of left ventricular oedema

  20. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Quantification of T2 before contrast agent

  21. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Quantification of T1 before contrast agent

  22. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Perfusion anomalies

  23. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Total volume of early left ventricular alteration

  24. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Total volume of late left ventricular alteration

  25. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Quantification of T1 after contrast agent

  26. Describe at the admission and during the treatment cardiac MRI parameters

    Time frame: 1 year

    Presence of a pericardial effusion

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: MYOCOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 5, 2020
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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