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

NCT04375748 | Completed

• 1 other identifier: RC31/20/0139
• Study Type: observational
• Target: 756
• Locations: 3 countries
• Sites: 64

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.

Conditions

Acute Myocarditis

Keywords

Covid19; Myocarditis; Epidemiology; Prognosis; Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Ultrasound characteristics.

  1 year

• Ultrasound characteristics.

  1 year

• Ultrasound characteristics.

  1 year

• Ultrasound characteristics.

  1 year

• Ultrasound characteristics.

  1 year

Study Arms (1)

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); Diagnostic Test: Examinations for the research:

Interventions

Performing routine care (clinical and paraclinical tests) DIAGNOSTIC_TEST

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

Patients treated for symptoms of acute myocarditis.

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)

Patients treated for symptoms of acute myocarditis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Refusal to participate.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (65)

Cardiology

Aix-en-Provence, France

Location

Reanimation

Amiens, France

Location

Cardiology

Angers, France

Location

Reanimation

Angers, France

Location

Cardiology

Avignon, France

Location

Cardiology

Bordeaux, France

Location

Pediatric cardiology

Bordeaux, France

Location

Reanimation

Bordeaux, France

Location

Cardiology

Brest, France

Location

Cardiology

Caen, France

Location

Pediatric Cardiology

Caen, France

Location

Cardiology

Clermont-Ferrand, France

Location

Pediatric cardilogy

Clermont-Ferrand, France

Location

Reanimation

Clermont-Ferrand, France

Location

Pediatric cardiology

Dijon, France

Location

Cardiology

Grenoble, France

Location

Pediatric cardiology

Grenoble, France

Location

Reanimation

Grenoble, France

Location

Cardiology

Lille, France

Location

Pediatric cardiology

Lille, France

Location

Pediatric cardiology

Limoges, France

Location

Cardiology

Lyon, France

Location

Pediatric cardiology

Lyon, France

Location

Cardiology

Marseille, France

Location

Pediatric cardiology

Marseille, France

Location

Cardiology

Metz, France

Location

Cardiology

Montpellier, France

Location

Millénaire Clinical - Cardiology

Montpellier, France

Location

Pediatric cardiology

Montpellier, France

Location

Reanimation

Montpellier, France

Location

Cardiology

Nancy, France

Location

Pediatric cardiology

Nancy, France

Location

Cardiology

Nantes, France

Location

Pediatric cardiology

Nantes, France

Location

Cardiology

Nice, France

Location

Pediatric cardiology

Nice, France

Location

Cardiology

Nîmes, France

Location

Cardiology, Henri Mondor Hospital

Paris, France

Location

Cardiology

Paris, France

Location

Henri Mondor Hospital Reanimation

Paris, France

Location

Marie Lannelongue Hospital - Pediatric Cardiology

Paris, France

Location

Marie Lannelongue Hospital Cardiology

Paris, France

Location

Reanimation

Paris, France

Location

Robert Debré Hospital - Pediatric cardiology

Paris, France

Location

Saint Antoine Hospital - Cardiology

Paris, France

Location

Cardiology

Poitiers, France

Location

Reanimation

Poitiers, France

Location

Pediatric cardiology

Reims, France

Location

Cardiology

Rennes, France

Location

Pediatric reanimation

Rennes, France

Location

Cardiology

Rouen, France

Location

Pediatric cardiology

Rouen, France

Location

Pédiatric cardiology

Strasbourg, France

Location

Reanimation

Strasbourg, France

Location

CHU de TOULOUSE

Toulouse, 31000, France

Location

Croix du Sud Clinical

Toulouse, France

Location

Pasteur Clinical - Cardiology

Toulouse, France

Location

Pasteur Clinical - Pediatric cardiology

Toulouse, France

Location

Pediatric Cardiology

Toulouse, France

Location

Cardiolgy

Tours, France

Location

Pediatric Cardiology

Tours, France

Location

Cardiology

Valenciennes, France

Location

Cardiology

Martinique, Martinique

Location

Cardiology

Mamoudzou, Mayotte

Location

Pédiatric cardiology

Réunion, Reunion

Location

MeSH Terms

Conditions

COVID-19; Myocarditis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Clément Delmas

  CHU Toulouse, Hôpital Rangueil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 5, 2020
• Study Start: April 15, 2020
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

MA (1); FR (62); RE (1)