Vascular Abnormalities Detected With Chest CT in COVID-19: Spectrum, Association With Other Lesions, and Correlation With Clinical Severity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Association of pulmonary embolism with ground glass opacity
研究概览
简要总结
Chest computed tomography of patients having coronavirus disease (COVID-19) will be analyzed with regards to vascular abnormalities (pulmonary embolism and vascular thickening), and their association with lung inflammation. The prevalence, severity, distribution, and prognostic value of chest CT findings will be assessed. Patients with vascular abnormalities will be compared to patients without, which is supposed to provide insights into the prognostic role of such abnormalities, and the potential impact on treatment strategy.
详细描述
Since the SARS-CoV-2 outbreak, computed tomography (CT) imaging has almost immediately established itself as the primary non-invasive diagnostic tool for diagnosis, monitoring of COVID-19 pneumonia, and complications thereof.
While most of the currently available literature relies on non-contrast CT, the need to assess vascular abnormalities is being recognized as an increasingly important factor, both to help distinguish COVID-19 pneumonia from other viral infections, and to exclude pulmonary embolism (PE). Acute PE is believed to be a significant contributory factor in patients with adverse outcomes.
Relating to vascular changes other than PE, additional knowledge is required and not yet available to confirm and better understand early observations. In particular, a radiological sign referred to as "vascular thickening", "vascular enlargement", or "vascular congestion" that is thought to be a specific marker of COVID-19 pneumonia, calls for a thorough assessment. Quantitative analysis of this sign and correlation to clinical presentation is highly desirable.
The investigators will conduct a multicentric observational study in the form of a registry. For this purpose, each participating center needs to screen hundreds of COVID-19 patients to select those who meet the inclusion criteria and do not have any exclusion criteria. Then, clinical, laboratory and imaging data of eligible patients will be retrieved. The research will focus on the imaging manifestations of COVID-19 pneumonia and their relationship to vascular abnormalities within the lung; the potential association between such vascular abnormalities and COVID-19 clinical severity will be assessed.
To achieve adequate statistical power, the study needs to be multicentric, involving 7 Swiss institutions; CHUV Lausanne, USZ Zurich, USB Basel, Inselspital Bern, Division Stadt- und Landspitäler Inselgruppe, HUG Genève, HRC Rennaz. The following investigators are involved in this extensive nationwide effort:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted for COVID-19 (with positive rt-PCR for SARS-CoV-2) who had a contrast-enhanced chest CT within the specified timeframe.
排除标准
- •Age <18 years Patients with another pre-existing infectious process Documented refusal of the reuse of medical data
结局指标
主要结局
Association of pulmonary embolism with ground glass opacity
时间窗: March 1st, 2020 to July 31st, 2020
Rate of PE in segments with vs. without COVID-19 ground glass opacity
Incidence of acute pulmonary embolism
时间窗: March 1st, 2020 to July 31st, 2020
Incidence of acute pulmonary embolism (PE).
Pulmonary embolism clot burden
时间窗: March 1st, 2020 to July 31st, 2020
Description of the clot burden of acute pulmonary embolism (PE) using the CT obstruction index
Distribution of acute pulmonary embolism
时间窗: March 1st, 2020 to July 31st, 2020
Description of the anatomical distribution (lobar and segmental level)
次要结局
- Vein-to-artery ratio(March 1st, 2020 to July 31st, 2020)
- Alveolar opacity(March 1st, 2020 to July 31st, 2020)
- Vascular volume(March 1st, 2020 to July 31st, 2020)
- PO2(March 1st, 2020 to July 31st, 2020)
- SaO2(March 1st, 2020 to July 31st, 2020)
- D-dimers(March 1st, 2020 to July 31st, 2020)
- CRP(March 1st, 2020 to July 31st, 2020)
- Vascular congestion(March 1st, 2020 to July 31st, 2020)
- ICU admission(March 1st, 2020 to July 31st, 2020)
- Clinical outcome(March 1st, 2020 to July 31st, 2020)
- Thrombocytes(March 1st, 2020 to July 31st, 2020)
研究者
Salah D. Qanadli
Prof. MD, PhD
University of Lausanne
