Clinical trial NCT04640428: COVID-19 Stroke Apical Lung Examination Study
Official title: COVID-19 Stroke Apical Lung Examination Study - A Multi-centre Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Stroke, Acute
Stroke, Ischemic
Stroke Hemorrhagic
Keywords: COVID
stroke
CT
CTA
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2020-11-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients presenting to participating centres with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test
timeFrame: 1 month
Secondary outcomes:
measure: Prognostic value of the computed tomography biomarker
timeFrame: 1 month
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Camberley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS FT (KCH)
city: London
country: United Kingdom
facility: King's College Hospital NHS FT (PRUH)
city: London
country: United Kingdom
facility: University College London NHS Foundation Trust
Study officials:
References: