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临床试验/NCT04375748
NCT04375748已完成不适用

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

University Hospital, Toulouse19 个研究点 分布在 3 个国家目标入组 756 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
756
试验地点
19
主要终点
Evolution of the proportion of positive SARS-COV-2 cases.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Refusal to participate.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Ultrasound characteristics.(1 year)
  • Describe at the admission and during the treatment cardiac MRI parameters(1 year)
  • Assess prognosis of the acute myocarditis .(The short-term (30 days) and long-term (1 year).)
  • The factors associated with acute myocarditis cases .(The short-term (30 days) and long-term (1 year).)
  • Biological characteristics(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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