COVID-19 Stroke Apical Lung Examination Study

Sponsor

King's College Hospital NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04640428

Collaborator

National Institute for Health Research, United Kingdom (Other)

2,000

Enrollment

Locations

15.7

Anticipated Duration (Months)

166.7

Patients Per Site

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Stroke, Acute Stroke, Ischemic Stroke Hemorrhagic

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 10, 2020

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Oct 31, 2021

Outcome Measures

Primary Outcome Measures

Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test [1 month]
Defined by sensitivity, specificity, positive and negative predictive values

Secondary Outcome Measures

Prognostic value of the computed tomography biomarker [1 month]
Defined by its relationship with 30 day mortality and modified rankin scale following treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Royal United Hospitals Bath NHS Foundation Trust	Bath	United Kingdom
2	North Bristol NHS Trust	Bristol	United Kingdom
3	University Hospitals Bristol NHS Foundation Trust	Bristol	United Kingdom
4	Frimley Health NHS Foundation Trust	Camberley	United Kingdom
5	Cardiff and Vale University Health Board	Cardiff	United Kingdom
6	University Hospitals Coventry and Warwickshire NHS Trust	Coventry	United Kingdom
7	Leeds Teaching Hospitals NHS Trust	Leeds	United Kingdom
8	Guy's and St Thomas' NHS Foundation Trust	London	United Kingdom
9	Imperial College Healthcare NHS Foundation Trust	London	United Kingdom
10	King's College Hospital NHS FT (KCH)	London	United Kingdom
11	King's College Hospital NHS FT (PRUH)	London	United Kingdom
12	University College London NHS Foundation Trust	London	United Kingdom