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NCT04640428 Clinical Trial

COVID-19 Stroke Apical Lung Examination Study

Covid19 Clinical Trial

Official title:
COVID-19 Stroke Apical Lung Examination Study - A Multi-centre Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04640428
Other study ID # COVID SALES 2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2020
Est. completion date October 31, 2021

Study information
Verified date May 2021
Source King's College Hospital NHS Trust
Contact Nathan Chan, FRCR
Phone +44(0)7508192126
Email covidsalesresearch@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multi-centre prospective study evaluating computed tomography angiography studies performed for stroke patients as a diagnostic and prognostic imaging biomarker.

Description:

Diagnosis of coronavirus disease 2019 (COVID-19) relies on clinical features and reverse-transcriptase polymerase chain reaction (RT-PCR) testing. The latter is constrained by limited sensitivity and a timescale of hours to yield results, with no point-of-care test widely available. A dedicated computed tomography study of the chest is likely to be more sensitive than RT-PCR for COVID-19. Carotid computed tomography angiography (CTA) is a routine acute stroke investigation and includes the lung apices. We aim to assess the lung apices on CTA for ground glass opacification and compare this with COVID-19 RT-PCR test results and clinical outcome measures.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All adult patients presenting with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation. Exclusion Criteria: Poor image quality. No radiologist report available. Computed tomography angiography performed in a non-acute setting.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal United Hospitals Bath NHS Foundation Trust Bath
United Kingdom North Bristol NHS Trust Bristol
United Kingdom University Hospitals Bristol NHS Foundation Trust Bristol
United Kingdom Frimley Health NHS Foundation Trust Camberley
United Kingdom Cardiff and Vale University Health Board Cardiff
United Kingdom University Hospitals Coventry and Warwickshire NHS Trust Coventry
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom Guy's and St Thomas' NHS Foundation Trust London
United Kingdom Imperial College Healthcare NHS Foundation Trust London
United Kingdom King's College Hospital NHS FT (KCH) London
United Kingdom King's College Hospital NHS FT (PRUH) London
United Kingdom University College London NHS Foundation Trust London

Sponsors (2)
Lead Sponsor Collaborator
King's College Hospital NHS Trust National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test Defined by sensitivity, specificity, positive and negative predictive values 1 month
Secondary Prognostic value of the computed tomography biomarker Defined by its relationship with 30 day mortality and modified rankin scale following treatment 1 month
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