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

Acute Myocarditis Clinical Trial

— MYOCOVID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375748
• Other study ID #: RC31/20/0139
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: December 28, 2021

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocarditis
• COVID-19
• Myocarditis

Intervention

Diagnostic Test:
• Performing routine care (clinical and paraclinical tests)
ECG, standard biology and cardiology tests, and routine transthoracic echocardiography (TTE), MRI
• 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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Countries where clinical trial is conducted

France,  Martinique,  Mayotte,  Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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).
Secondary	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).
Secondary	Biological characteristics	Describe the biological parameters on admission and during the treatment (troponinemia (ng/ml)	1 year
Secondary	Biological characteristics	Describe the biological parameters on admission and during the treatment NtproBNP(pg/ml)	1 year
Secondary	Biological characteristics	Describe the biological parameters on admission and during the treatment CRP(mg/ml)	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Ventricular volumes (ml)	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Systole Diameter	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Diastole Diameter	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Longitudinal deformation of left ventricle;	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Longitudinal deformation of right ventricle;	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Total volume of left ventricular oedema	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Quantification of T2 before contrast agent	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Quantification of T1 before contrast agent	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Perfusion anomalies	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Total volume of early left ventricular alteration	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Total volume of late left ventricular alteration	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Quantification of T1 after contrast agent	1 year
Secondary	Describe at the admission and during the treatment cardiac MRI parameters	Presence of a pericardial effusion	1 year