Radiological Imaging in Patients Tested for COVID-19

September 16, 2024 updated by: University of Edinburgh
It has become apparent that patients with co-morbidities have an increased risk of mortality from coronarvirus disease 2019 (COVID-19). However, the impact of subclinical respiratory and cardiovascular disease on the outcome of patients with COVID-19 is currently unknown. This observational study will assess the impact of incidental cardiovascular calcification on radiological imaging on the outcomes of patients with COVD-19.

Study Overview

Status

Completed

Conditions

Detailed Description

It has become apparent that patients with co-morbidities have an increased risk of mortality from coronarvirus disease 2019 (COVID-19). However, the impact of subclinical respiratory and cardiovascular disease on the outcome of patients with COVID-19 is currently unknown.

Subclinical respiratory and cardiovascular disease can be identified on radiological imaging. For example, calcification in blood vessels can identify cardiovascular disease, intra-thoracic and intra-abdominal fat is associated with coronary artery disease, and lung diseases can be identified on CT and x-ray. The impact these radiological features on the outcomes of patients with COVID-19 is currently unknown.

This study aims to assess the radiological imaging of patients tested for COVID-19 in order to identify the presence of co-existing respiratory and cardiovascular disease and assess their impact on clinical outcomes.

All patients tested for COVID-19 with current or previous (last 3 years) radiological imaging will be included in this study. Radiological images will be de-identified and assessed for the presence of cardiovascular calcification. Information on COVID-19 tests and clinical factors will be obtained from routinely collected data. Additional clinical information will be obtained from electronic health records as required.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SA
        • University of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Positive RT-PCR test for COVID-19 with radiological imaging available within the last 3 years.

Description

Inclusion Criteria:

  • One or more positive RT-PCR test for COVID-19.
  • One or more CT or chest x-ray available performed within the last 3 years

Exclusion Criteria:

  • No available radiological imaging within the last 3 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COVID-19
Patients tested for COVID-19 with current or previous (last 3 years) radiological imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 1 month
All cause mortality
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 1 month
Cardiovascular mortality
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarction
Time Frame: 1 month
Myocardial infarction
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/WA/0184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not possible due to data collection method.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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