- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696913
Does COVID-19 Infection Increase the Risk of Pulmonary Embolism?
Does COVID-19 Infection Increase the Risk of Pulmonary Embolism? A Retrospective Case-control Study
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.
Study Overview
Status
Conditions
Detailed Description
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.
Patients' exposure status will also be determined (positive or negative for COVID- 19 infection).
The primary outcome is the number of pulmonary embolism cases related to COVID19.
The secondary outcomes are the severity, distribution of pulmonary embolism as determined by calculated Qanadli score. Presence of right heart strain.
Further data for the multivariate analysis will be obtained from the patient's electronic medical record. Specifically, we will collect data on risk factors for COVID-19 infection and PE to correct for confounding.
Statistical data analysis by various hypothesis tests and multivariate logistic regression will be conducted to determine the odds ratio of developing a PE, given positive COVID-19 infection.
Patients with a positive PE will have their scans reviewed to quantitatively assess their clot burden and degree of right heart strain. The former will be done by calculating a Qanadil score. The latter will be done my measuring the right ventricle- left ventricle ratio. This will allow for a comparison between COVID-19 infected and non-infected patients with PE.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aberdeen, United Kingdom
- Aberdeen Royal Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-Patients who had a CT pulmonary angiogram at NHS Grampian between 3rd March and 20th June 2020.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Pulmonary Embolism Positive
As determined by CT Pulmonary Angiogram
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Exposure: Positive COVID-19 infection as determined by RT-PCR
Exposure: Negative COVID-19 infection as determined by RT-PCR
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Pulmonary Embolism Negative
As determined by CT Pulmonary Angiogram
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Exposure: Positive COVID-19 infection as determined by RT-PCR
Exposure: Negative COVID-19 infection as determined by RT-PCR
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of pulmonary embolism cases related to COVID-19.
Time Frame: 109 days
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109 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Severity, distribution of pulmonary embolism as determined by calculated Qanadli score.
Time Frame: 109 days
|
Qanadli Score: The arterial tree of each lung is regarded as having 10 segmental PAs (three to the upper lobes,two to the middle lobe or lingula, and five to the lower lobes).
The presence of an embolus in a segmental PA is scored as 1 point, and emboli at the most proximal arterial level are scored a value equal to the number of segmental PAs arising distally.
To provide additional information on the residual perfusion distal to the embolus, a weighting factor is used for each value (0 for no defect, 1 for partial occlusion, and 2 for complete occlusion).
An isolated subsegmental embolus is considered a partially occluded segmental PA and is assigned a value of 1.
The maximum CT obstruction index is 40.
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109 days
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Presence of right heart strain associated with pulmonary embolism.
Time Frame: 109 days
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As determined on CT by the presence of straightening of the interventricular septum and/or contrast reflux into the inferior vena cava and/or pulmonary artery measurements
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109 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Pulmonary Embolism
Other Study ID Numbers
- 1-073-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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