Electrocardiogram Analysis in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,014
- 试验地点
- 1
- 主要终点
- Phase 1: ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection
研究概览
简要总结
Electrocardiographic (ECG) evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infection.
The present study involves three different phases of evaluation of the ECG traces of hospitalized patients with SARS-CoV-2 infection.
- Phase 1: it is proposed to collect and retrospectively analyze the ECGs of hospitalized patients with severe SARS-CoV-2 infection which led to invasive ventilation or patient death as a consequence and, if available, also possible troponin dosage;
- Phase 2: aims to collect and analyze the ECGs of consecutive hospitalized patients with SARS-CoV-2 infection and evaluate their relationship with the course of the disease, cardiac involvement and prognosis;
- Phase 3: it is proposed to repeat ECG and to carry out echocardiogram to patients with SARS-CoV-2 infection after 3 months from hospital discharge by simultaneously performing, if deemed clinically indicated, also cardiac magnetic resonance. In this phase, any evolutions of ECG alterations of the acute phase will be described and the relationship with cardiac involvement will be assessed.
详细描述
In the early months of 2020, SARS-CoV-2 virus infection quickly spread around the world to a pandemic. On 2 April 2020, confirmed cases of coronavirus disease 2019 (COVID-19) worldwide exceeded one million and an unprecedented health crisis has occurred in recent history.
SARS-CoV-2 disease can lead to the development of even severe pneumonia with the need for ventilatory support and in some cases fatal outcome.
From the data currently present in the literature, important relationships emerge between infection and cardiovascular diseases. COVID-19 patients with underlying pre-existing heart disease or cardiovascular risk factors have a more severe course of the disease and are more at risk of adverse outcomes and death than individuals with no history of heart disease or risk factors.
During the course of the infection, some patients even without previous heart disease may experience myocardial injury and this leads to a significant increase in in-hospital mortality. Myocardial pain during SARS-CoV-2 infection is associated with cardiac dysfunction and arrhythmias.
To date, there are no data on the role of the electrocardiogram neither in the diagnosis of cardiac involvement nor in predicting the prognosis of patients with SARS-CoV-2 infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years old
- •confirmed SARS-CoV-2 infection (pharyngeal swab positive for viral RNA or clinical diagnosis of COVID-19 based on chest x-ray or high resolution CT)
- •hospitalization in a hospital setting
排除标准
- •SARS-CoV-2 infection not confirmed by pharyngeal swab or clinical-radiographic criteria
- •absence of ECG tracing performed at the time of hospitalization
结局指标
主要结局
Phase 1: ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection
时间窗: 1 month
Describe the ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection
Phase 2: Correlation between ECG signs and needs for invasive mechanical ventilation and/or mortality in the acute phase
时间窗: 6 months
To evaluate the correlation between ECG signs and cardiac involvement in the acute phase • Assess the correlation between ECG signs and mortality in the acute phase
Phase 3: Correlation between ECG signs and cardiac involvement and mortality in the chronic phase
时间窗: 12 months
To evaluate the correlation between acute phase ECG signs and chronic phase cardiac involvement • evaluate the appearance, in the short-term follow-up, of signs of cardiac involvement (cardiomyopathies and conduction disorders in particular)
次要结局
未报告次要终点