COVID-19NCT05188443
Radiological Imaging in Patients Tested for COVID-19
An observational study of COVID-19 and Coronary Artery Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronary Artery Disease, Cardiovascular Diseases
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2020to 1 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Positive RT-PCR test for COVID-19 with radiological imaging available within the last 3 years.
Who may be able to join
- 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
Who cannot join
- No available radiological imaging within the last 3 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh
Edinburgh, Scotland, EH16 4SA
About this study
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.
Read the 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.
- Conditions
- COVID-19, Coronary Artery Disease, Cardiovascular Diseases
- Medical subject headings
- COVID-19, Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Patients tested for COVID-19 with current or previous (last 3 years) radiological imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
All cause mortality
Measured: 1 month
Secondary outcomes (1)
Cardiovascular mortality
Cardiovascular mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Aug 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188443
- Sponsor's protocol ID
- 20/WA/0184
- Status last verified
- Sep 2024
- First submitted
- 5 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not possible due to data collection method.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Imaging in Patients Tested for COVID-19
- ClinicalTrials.gov ID
- NCT05188443
- Acronym / sponsor ID
- 20/WA/0184
- Conditions
- COVID-19, Coronary Artery Disease, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 12 Jan 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | –Patients tested for COVID-19 with current or previous (last 3 years) radiological imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Positive RT-PCR test for COVID-19 with radiological imaging available within the last 3 years.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- No available radiological imaging within the last 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: 1 month
All cause mortality
1 secondary outcome
Cardiovascular mortality
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Not possible due to data collection method.
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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 COVID-19 and Coronary Artery Disease, run by University of Edinburgh at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All cause mortality (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.