Vascular Abnormalities Detected With Chest CT in COVID-19

Covid19 Clinical Trial

— COVID-CAVA  

Official title:

Vascular Abnormalities Detected With Chest CT in COVID-19: Spectrum, Association With Other Lesions, and Correlation With Clinical Severity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04824313
• Other study ID #: 2020-1469
• Status: Active, not recruiting
• Start date: March 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2021
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2021
• Est. primary completion date: July 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted for COVID-19 (with positive rt-PCR for SARS-CoV-2) who had a contrast-enhanced chest CT within the specified timeframe.

Exclusion Criteria:

• Age <18 years Patients with another pre-existing infectious process Documented refusal of the reuse of medical data

Related Conditions & MeSH terms

• Congenital Abnormalities
• Covid19
• Embolism
• Pneumonia
• Pneumonia, Viral
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Chest CT
Chest CT without intravenous contrast material
• Chest CTA
Chest CT with intravenous contrast material

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (5)

Lead Sponsor	Collaborator
Salah D. Qanadli	University of Basel, University of Bern, University of Geneva, Switzerland, University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Qanadli SD, Beigelman-Aubry C, Rotzinger DC. Vascular Changes Detected With Thoracic CT in Coronavirus Disease (COVID-19) Might Be Significant Determinants for Accurate Diagnosis and Optimal Patient Management. AJR Am J Roentgenol. 2020 Jul;215(1):W15. doi: 10.2214/AJR.20.23185. Epub 2020 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute pulmonary embolism	Incidence of acute pulmonary embolism (PE).	March 1st, 2020 to July 31st, 2020
Primary	Distribution of acute pulmonary embolism	Description of the anatomical distribution (lobar and segmental level)	March 1st, 2020 to July 31st, 2020
Primary	Pulmonary embolism clot burden	Description of the clot burden of acute pulmonary embolism (PE) using the CT obstruction index	March 1st, 2020 to July 31st, 2020
Primary	Association of pulmonary embolism with ground glass opacity	Rate of PE in segments with vs. without COVID-19 ground glass opacity	March 1st, 2020 to July 31st, 2020
Secondary	Clinical outcome	Outcome will be registered in a categorical variable as outpatient, inpatient without intubation, inpatient with intubation, death	March 1st, 2020 to July 31st, 2020
Secondary	D-dimers	D-dimer serum sampling (ng/mL), continuous variable	March 1st, 2020 to July 31st, 2020
Secondary	PO2	Arterial blood oxygen partial pressure (PO2, mmHg), continuous variable	March 1st, 2020 to July 31st, 2020
Secondary	SaO2	Venous blood oxygen saturation (SaO2, in %), continuous variable	March 1st, 2020 to July 31st, 2020
Secondary	CRP	C-reactive protein serum sampling (mg/L), continuous variable	March 1st, 2020 to July 31st, 2020
Secondary	Thrombocytes	Blood thrombocyte count (number per liter), continuous variable	March 1st, 2020 to July 31st, 2020
Secondary	ICU admission	Rate of patients admitted in the intensive care unit (ICU)	March 1st, 2020 to July 31st, 2020
Secondary	Alveolar opacity	Rate of lung segments with alveolar opacity	March 1st, 2020 to July 31st, 2020
Secondary	Vascular congestion	Rate of lung segments with vascular congestion	March 1st, 2020 to July 31st, 2020
Secondary	Vascular volume	Vascular volume measured at the segmental level (in mL), continuous variable	March 1st, 2020 to July 31st, 2020
Secondary	Vein-to-artery ratio	The vein-to-artery ratio will be calculated at the segmental level (venous diameter [mm] / arterial diamter [mm]), continuous variable	March 1st, 2020 to July 31st, 2020