Covid19COVID-CAVANCT04824313
Vascular Abnormalities Detected With Chest CT in COVID-19
An observational study of Covid19 and Pneumonia, Viral, run by Salah D. Qanadli at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Pneumonia, Viral, Pulmonary Embolism
- What is being tested?
- Chest CT and Chest CTA
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2020to 31 Mar 2021
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients with positive rt-PCR for SARS-CoV-2 and chest CT (with or without intravenous contrast material injection) within the specified time frame.
Who may be able to join
- Patients admitted for COVID-19 (with positive rt-PCR for SARS-CoV-2) who had a contrast-enhanced chest CT within the specified timeframe.
Who cannot join
- Age <18 years Patients with another pre-existing infectious process Documented refusal of the reuse of medical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Abnormalities Detected With Chest CT in COVID-19: Spectrum, Association With Other Lesions, and Correlation With Clinical Severity
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.
Read the 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.
- Conditions
- Covid19, Pneumonia, Viral, Pulmonary Embolism
- Being tested
- Chest CT, Chest CTA
- Keywords
- COVID-19, Computed tomography, Vascular abnormalities, Lung infection, Thromboembolism
- Medical subject headings
- COVID-19, Pneumonia, Viral, Pulmonary Embolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CTDiagnostic test
Chest CT without intravenous contrast material
Chest CTADiagnostic test
Chest CT with intravenous contrast material
| Study group | Role | What they receive |
|---|---|---|
| COVID-CAVA PE | Patients with RT-PCR proven COVID-19 disease and CTA proven pulmonary embolism Receives: Diagnostic Test: Chest CTA | |
| COVID-CAVA non-PE | Patients with RT-PCR proven COVID-19 disease and no evidence of pulmonary embolism on CT Receives: Diagnostic Test: Chest CT; Diagnostic Test: Chest CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute pulmonary embolism
Incidence of acute pulmonary embolism (PE).
Measured: March 1st, 2020 to July 31st, 2020
Distribution of acute pulmonary embolism
Description of the anatomical distribution (lobar and segmental level)
Measured: March 1st, 2020 to July 31st, 2020
Pulmonary embolism clot burden
Description of the clot burden of acute pulmonary embolism (PE) using the CT obstruction index
Measured: March 1st, 2020 to July 31st, 2020
Association of pulmonary embolism with ground glass opacity
Rate of PE in segments with vs. without COVID-19 ground glass opacity
Measured: March 1st, 2020 to July 31st, 2020
Secondary outcomes (11)
Clinical outcome
Outcome will be registered in a categorical variable as outpatient, inpatient without intubation, inpatient with intubation, death
Measured: March 1st, 2020 to July 31st, 2020
D-dimers
D-dimer serum sampling (ng/mL), continuous variable
Measured: March 1st, 2020 to July 31st, 2020
PO2
Arterial blood oxygen partial pressure (PO2, mmHg), continuous variable
Measured: March 1st, 2020 to July 31st, 2020
SaO2
Venous blood oxygen saturation (SaO2, in %), continuous variable
Measured: March 1st, 2020 to July 31st, 2020
CRP
C-reactive protein serum sampling (mg/L), continuous variable
Measured: March 1st, 2020 to July 31st, 2020
Thrombocytes
Blood thrombocyte count (number per liter), continuous variable
Measured: March 1st, 2020 to July 31st, 2020
ICU admission
Rate of patients admitted in the intensive care unit (ICU)
Measured: March 1st, 2020 to July 31st, 2020
Alveolar opacity
Rate of lung segments with alveolar opacity
Measured: March 1st, 2020 to July 31st, 2020
Vascular congestion
Rate of lung segments with vascular congestion
Measured: March 1st, 2020 to July 31st, 2020
Vascular volume
Vascular volume measured at the segmental level (in mL), continuous variable
Measured: March 1st, 2020 to July 31st, 2020
Vein-to-artery ratio
The vein-to-artery ratio will be calculated at the segmental level (venous diameter [mm] / arterial diamter [mm]), continuous variable
Measured: March 1st, 2020 to July 31st, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Mar 2020
- Primary completion31 Jul 2020
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Salah D. Qanadli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, University of Bern, University of Basel, University of Zurich
- Responsible party
- Sponsor-investigator, Salah D. Qanadli, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824313
- Sponsor's protocol ID
- 2020-1469
- Acronym
- COVID-CAVA
- Status last verified
- Mar 2021
- First submitted
- 18 Feb 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. No abstract available.
PubMed 32255684Nevesny F, Rotzinger DC, Sauter AW, Loebelenz LI, Schmuelling L, Alkadhi H, Ebner L, Christe A, Platon A, Poletti PA, Qanadli SD. Acute Pulmonary Embolism in COVID-19: A Potential Connection between Venous Congestion and Thrombus Distribution. Biomedicines. 2022 Jun 2;10(6):1300. doi: 10.3390/biomedicines10061300.
PubMed 35740322
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Abnormalities Detected With Chest CT in COVID-19: Spectrum, Association With Other Lesions, and Correlation With Clinical Severity
- ClinicalTrials.gov ID
- NCT04824313
- Acronym / sponsor ID
- COVID-CAVA / 2020-1469
- Conditions
- Covid19, Pneumonia, Viral, Pulmonary Embolism
- Keywords
- COVID-19, Computed tomography, Vascular abnormalities, Lung infection, Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Salah D. QanadliUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, University of Bern, University of Basel, University of Zurich
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-CAVA PE | – | Diagnostic Test: Chest CTAPatients with RT-PCR proven COVID-19 disease and CTA proven pulmonary embolism |
| COVID-CAVA non-PE | – | Diagnostic Test: Chest CT, Diagnostic Test: Chest CTAPatients with RT-PCR proven COVID-19 disease and no evidence of pulmonary embolism on CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with positive rt-PCR for SARS-CoV-2 and chest CT (with or without intravenous contrast material injection) within the specified time frame.
Key inclusion criteria (1 listed)
- Patients admitted for COVID-19 (with positive rt-PCR for SARS-CoV-2) who had a contrast-enhanced chest CT within the specified timeframe.
Key exclusion criteria (1 listed)
- Age <18 years Patients with another pre-existing infectious process Documented refusal of the reuse of medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CTChest CT without intravenous contrast material | Diagnostic test | COVID-CAVA non-PE |
| Chest CTAChest CT with intravenous contrast material | Diagnostic test | COVID-CAVA PE, COVID-CAVA non-PE |
Primary outcome
Incidence of acute pulmonary embolism
Time frame: March 1st, 2020 to July 31st, 2020
Incidence of acute pulmonary embolism (PE).
Distribution of acute pulmonary embolism
Time frame: March 1st, 2020 to July 31st, 2020
Description of the anatomical distribution (lobar and segmental level)
Pulmonary embolism clot burden
Time frame: March 1st, 2020 to July 31st, 2020
Description of the clot burden of acute pulmonary embolism (PE) using the CT obstruction index
Association of pulmonary embolism with ground glass opacity
Time frame: March 1st, 2020 to July 31st, 2020
Rate of PE in segments with vs. without COVID-19 ground glass opacity
11 secondary outcomes
Clinical outcome
Time frame: March 1st, 2020 to July 31st, 2020
D-dimers
Time frame: March 1st, 2020 to July 31st, 2020
PO2
Time frame: March 1st, 2020 to July 31st, 2020
SaO2
Time frame: March 1st, 2020 to July 31st, 2020
CRP
Time frame: March 1st, 2020 to July 31st, 2020
Thrombocytes
Time frame: March 1st, 2020 to July 31st, 2020
ICU admission
Time frame: March 1st, 2020 to July 31st, 2020
Alveolar opacity
Time frame: March 1st, 2020 to July 31st, 2020
Vascular congestion
Time frame: March 1st, 2020 to July 31st, 2020
Vascular volume
Time frame: March 1st, 2020 to July 31st, 2020
Vein-to-artery ratio
Time frame: March 1st, 2020 to July 31st, 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 32255684Qanadli 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. No abstract available.
- Derived from this study: PubMed 35740322Nevesny F, Rotzinger DC, Sauter AW, Loebelenz LI, Schmuelling L, Alkadhi H, Ebner L, Christe A, Platon A, Poletti PA, Qanadli SD. Acute Pulmonary Embolism in COVID-19: A Potential Connection between Venous Congestion and Thrombus Distribution. Biomedicines. 2022 Jun 2;10(6):1300. doi: 10.3390/biomedicines10061300.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Pneumonia, Viral, run by Salah D. Qanadli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute pulmonary embolism (time frame: March 1st, 2020 to July 31st, 2020). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824313, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.