Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696913
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2020-11-19
Brief Title:
Does COVID-19 Infection Increase the Risk of Pulmonary Embolism
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
Does COVID-19 Infection Increase the Risk of Pulmonary Embolism A Retrospective Case-control Study
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 143 million confirmed cases and over 600000 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 PEConfirming 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
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 PEConfirming 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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None