Vascular Abnormalities Detected With Chest CT in COVID-19
- Conditions
- Pulmonary EmbolismCovid19Pneumonia, Viral
- Interventions
- Diagnostic Test: Chest CTDiagnostic Test: Chest CTA
- Registration Number
- NCT04824313
- Lead Sponsor
- Salah D. Qanadli
- Brief Summary
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.
- Detailed Description
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:
* CHUV: Dr DC Rotzinger; Prof SD Qanadli; Prof PY Bochud; Prof L Alberio; Dr JL Pagani
* USZ: Prof H Alkadhi
* USB: Prof J Bremerich; Dr A Sauter
* Inselspital: Prof T Heverhagen; Prof L Ebner
* Division Stadt- und Landspitäler Inselgruppe: Prof A Christe
* HUG: Prof A Poletti
* HRC: Prof O Ratib
Intrahospital medical records, laboratory tests results, and data from chest CT performed in the participating centers between March 1st and July 31st, 2020 will be used to:
* assess the frequency of non-PE related vascular abnormalities on chest CT (vascular thickening), and their association with parenchymal opacities
* evaluate the rate of acute PE among the patients undergoing contrast-enhanced chest CT
* quantify the clot burden in terms of proximal or distal obstruction and quantitative CT obstruction index (CTOI) in patients with CT-proven PE
* evaluate the consequence of PE on pulmonary perfusion (distinguishing perfused vs. non-perfused pulmonary opacities) and cardiac morphology (right ventricle dilatation, reduced left atrial size)
* evaluate the correlation between pulmonary perfusion impairment and clinical severity
Using clinical, laboratory and CT imaging-derived variables, the investigators will perform outcome modelling to derive an integrative score to predict outcomes.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Patients admitted for COVID-19 (with positive rt-PCR for SARS-CoV-2) who had a contrast-enhanced chest CT within the specified timeframe.
- Age <18 years Patients with another pre-existing infectious process Documented refusal of the reuse of medical data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-CAVA non-PE Chest CT Patients with RT-PCR proven COVID-19 disease and no evidence of pulmonary embolism on CT COVID-CAVA PE Chest CTA Patients with RT-PCR proven COVID-19 disease and CTA proven pulmonary embolism COVID-CAVA non-PE Chest CTA Patients with RT-PCR proven COVID-19 disease and no evidence of pulmonary embolism on CT
- Primary Outcome Measures
Name Time Method Association of pulmonary embolism with ground glass opacity March 1st, 2020 to July 31st, 2020 Rate of PE in segments with vs. without COVID-19 ground glass opacity
Pulmonary embolism clot burden March 1st, 2020 to July 31st, 2020 Description of the clot burden of acute pulmonary embolism (PE) using the CT obstruction index
Incidence of acute pulmonary embolism March 1st, 2020 to July 31st, 2020 Incidence of acute pulmonary embolism (PE).
Distribution of acute pulmonary embolism March 1st, 2020 to July 31st, 2020 Description of the anatomical distribution (lobar and segmental level)
- Secondary Outcome Measures
Name Time Method Vascular volume March 1st, 2020 to July 31st, 2020 Vascular volume measured at the segmental level (in mL), continuous variable
Vein-to-artery ratio March 1st, 2020 to July 31st, 2020 The vein-to-artery ratio will be calculated at the segmental level (venous diameter \[mm\] / arterial diamter \[mm\]), continuous variable
D-dimers March 1st, 2020 to July 31st, 2020 D-dimer serum sampling (ng/mL), continuous variable
CRP March 1st, 2020 to July 31st, 2020 C-reactive protein serum sampling (mg/L), continuous variable
Vascular congestion March 1st, 2020 to July 31st, 2020 Rate of lung segments with vascular congestion
Alveolar opacity March 1st, 2020 to July 31st, 2020 Rate of lung segments with alveolar opacity
PO2 March 1st, 2020 to July 31st, 2020 Arterial blood oxygen partial pressure (PO2, mmHg), continuous variable
SaO2 March 1st, 2020 to July 31st, 2020 Venous blood oxygen saturation (SaO2, in %), continuous variable
ICU admission March 1st, 2020 to July 31st, 2020 Rate of patients admitted in the intensive care unit (ICU)
Clinical outcome March 1st, 2020 to July 31st, 2020 Outcome will be registered in a categorical variable as outpatient, inpatient without intubation, inpatient with intubation, death
Thrombocytes March 1st, 2020 to July 31st, 2020 Blood thrombocyte count (number per liter), continuous variable
Trial Locations
- Locations (1)
CHUV
🇨🇭Lausanne, Vaud, Switzerland