Radiological Imaging in Patients Tested for COVID-19

Sponsor

University of Edinburgh (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05188443

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

28.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. This observational study will assess the impact of incidental cardiovascular calcification on radiological imaging on the outcomes of patients with COVD-19.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Coronary Artery Disease Cardiovascular Diseases

Detailed Description

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

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Radiological Imaging in Patients Tested for COVID-19

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 Patients tested for COVID-19 with current or previous (last 3 years) radiological imaging

Outcome Measures

Primary Outcome Measures

All cause mortality [1 month]
All cause mortality

Secondary Outcome Measures

Cardiovascular mortality [1 month]
Cardiovascular mortality

Other Outcome Measures

Myocardial infarction [1 month]
Myocardial infarction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Edinburgh	Edinburgh	Scotland	United Kingdom	EH16 4SA

Sponsors and Collaborators

University of Edinburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Edinburgh

ClinicalTrials.gov Identifier:

NCT05188443

Other Study ID Numbers:

20/WA/0184

First Posted:

Jan 12, 2022

Last Update Posted:

Jan 12, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Cardiovascular Diseases

Coronary Artery Disease

Study Results

No Results Posted as of Jan 12, 2022