Does COVID-19 Infection Increase the Risk of Pulmonary Embolism? A Retrospective Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- Number of pulmonary embolism cases related to COVID-19.
研究概览
简要总结
The World Health Organization (WHO) declared the 2019 novel coronavirus (COVID-19) a pandemic on March 11, 2020. As of 19 July 2020, there have been 14.3 million confirmed cases and over 600,000 confirmed deaths. Up to 14% of infected patients develop interstitial pneumonia, which may evolve to acute respiratory distress syndrome.
COVID-19 associated pulmonary arterial microthrombosis and coagulopathy has prompted physicians to implicate pulmonary embolism (PE) as a potential cause for acute respiratory deterioration.
Literature review reveals few studies of varying size, quality and design. Recent meta-analysis reports venous thromboembolism in approximately 20% of COVID-19 patients. There has yet to be a case-controlled study which proves and quantifies the associated between COVID-19 and PE.Confirming and quantifying this association has numerous clinical implications for the treatment of critically unwell patients with COVID-19 infection. For example, clinicians will be more inclined to investigate and treat sudden deteriorations with the knowledge that pulmonary embolism is the commonest cause for said deteriorations.
详细描述
A retrospective case-control study of all patients who had a CT pulmonary angiogram (CTPA) at NHS Grampian between 3rd March and 20th June 2020 will be conducted.
CTPA reports and test results of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) for COVID-19 will be reviewed via electronic medical records.
Patients with no COVID-19 RT-PCR test done within 7 days of the CTPA or the same clinical episode will be excluded. Patients who had repeat CTPAs, who are already known to have a PE, and who had CTPAs which are considered to be radiologically inadequate will be excluded.
Patients will be categorised into cases (positive PE) and controls (negative PE).
CTPA images of cases will be reviewed to collect further data about severity, distribution and right heart strain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had a CT pulmonary angiogram at NHS Grampian between 3rd March and 20th June 2020.
排除标准
- •Patients with no COVID-19 RT-PCR test done within 7 days of the CT pulmonary angiogram or the same clinical episode.
- •Duplicate CT pulmonary angiograms.
- •Patients who are already known to have a pulmonary embolism.
- •Patients who had radiologically inadequate CT pulmonary angiograms.
- •Patients younger than 16 years old.
- •Patients who have incomplete or unavailable notes.
研究组 & 干预措施
Pulmonary Embolism Positive
As determined by CT Pulmonary Angiogram
干预措施: Exposure: Positive COVID-19 infection (Diagnostic Test)
Pulmonary Embolism Positive
As determined by CT Pulmonary Angiogram
干预措施: Exposure: Negative COVID-19 infection (Diagnostic Test)
Pulmonary Embolism Negative
As determined by CT Pulmonary Angiogram
干预措施: Exposure: Positive COVID-19 infection (Diagnostic Test)
Pulmonary Embolism Negative
As determined by CT Pulmonary Angiogram
干预措施: Exposure: Negative COVID-19 infection (Diagnostic Test)
结局指标
主要结局
Number of pulmonary embolism cases related to COVID-19.
时间窗: 109 days
次要结局
- Severity, distribution of pulmonary embolism as determined by calculated Qanadli score.(109 days)
- Presence of right heart strain associated with pulmonary embolism.(109 days)