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

NCT ID: NCT04375748

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 756 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2021-12-28

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.

Conditions

Acute Myocarditis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Performing routine care (clinical and paraclinical tests)

Intervention Type: DIAGNOSTIC_TEST

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

Examinations for the research:

Intervention Type: 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)

Interventions

Performing routine care (clinical and paraclinical tests)

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

Intervention Type: 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)

Intervention Type: DIAGNOSTIC_TEST

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clément Delmas

Role: PRINCIPAL_INVESTIGATOR

CHU Toulouse, Hôpital Rangueil

Locations

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, 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

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, , France

Cardiology

Martinique, , Martinique

Cardiology

Mamoudzou, , Mayotte

Pédiatric cardiology

Réunion, , Reunion

Countries

France; Martinique; Mayotte; Reunion

Other Identifiers

RC31/20/0139

Identifier Type: -

Identifier Source: org_study_id